Description
General Instructions
Side Effects
Uses
Safety advice
Warnings
Dosage
Interactions
FAQs
Other Details
References
Disclaimer

Norco: Uses, Dosage & Safety Information

Norco

Hydrocodone bitartrate; acetaminophen

Norco was a brand of hydrocodone with acetaminophen; every Norco strength is now listed by the FDA as discontinued. A prescription written for Norco today is filled with generic hydrocodone bitartrate and acetaminophen tablets, a Schedule II opioid combination with 325 mg of acetaminophen per tablet and strength-specific daily limits.

ActiveIngredient: Hydrocodone bitartrate; acetaminophen
DosageForm: Tablet
Dosage: 5/325 mg, 7.5/325 mg, 10/325 mg (generic)
Indications: Pain severe enough to require an opioid analgesic when alternatives are inadequate
Manufacturer: Brand discontinued; generic manufacturers (e.g., SpecGx)
Storage: Store at room temperature; keep secured and dispose of unused tablets properly
Drug Status: Discontinued

Drug Status: Discontinued

iMedix Editorial Team | Updated: 28.09.26

Description

What is Norco?

The brand is gone; the prescription is not

Every strength of Norco under its original application is listed by the FDA as discontinued. A prescription written as “Norco” is filled with generic hydrocodone bitartrate and acetaminophen tablets; the FDA reference standards for these are generic SpecGx tablets rated AA. One repackager still labels a SpecGx 10/325 tablet as “Norco” under the generic application.²⁴³

The medicine behind the name combines hydrocodone bitartrate, a Schedule II opioid, with acetaminophen in every tablet. The liver converts hydrocodone mainly through CYP3A4 to norhydrocodone, with a smaller share turned into hydromorphone by CYP2D6.¹

Because two drugs share each tablet, the labelling carries boxed warnings for both: opioid addiction, respiratory depression, accidental ingestion, neonatal withdrawal, sedative and CYP3A4 interactions, and acetaminophen liver injury.¹

Norco was approved in February 1997 under ANDA 040148, in four strengths; a second Norco application from June 1997 is also discontinued. Marketed generic tablets contain the same two active ingredients at the 5/325, 7.5/325 and 10/325 strengths.²

A related page covers Lorcet, a brand whose only listed product used a higher acetaminophen content per tablet.

▶Clinical detailsstatus by application

Norco and Its Generic Replacements
Application	Product	FDA status
ANDA 040148	Norco 2.5, 5, 7.5, 10 mg/325 mg	Discontinued
ANDA 040099	Norco 5 mg/325 mg	Discontinued
ANDA 040400	Generic 10 mg/325 mg (SpecGx)	Marketed; reference standard, AA
ANDA 040405 / 040409	Generic 7.5/325 and 5/325 (SpecGx)	Marketed; reference standards

Source: ²⁴

General Instructions

How to Take Norco

Check the strength, not the name

Your bottle will usually say hydrocodone bitartrate and acetaminophen rather than Norco. The strength on the label sets the dose and the daily limit.¹

How often

Treatment starts at the lowest effective dose: with 5/325, 1 to 2 tablets every 4 to 6 hours as needed; with 7.5/325 or 10/325, one tablet every 4 to 6 hours as needed. No more than 8 tablets a day of 5/325, or 6 a day of the stronger tablets. The labelling gives no instruction about food.¹

Switching and other acetaminophen

When switching from another opioid, it is safer to underestimate the 24-hour dose than to overestimate it. Check other medicines for acetaminophen, because most serious acetaminophen harm involved more than 4,000 mg a day, often from more than one product.¹

What not to do

Do not assume a new strength has the same daily tablet limit as the old one, and do not stop abruptly after regular use; the dose is reduced gradually.¹

Side Effects

What Are the Side Effects of Norco?

Post-approval reports, not controlled trials, are the source of the reactions below, so no reliable rates can be given.¹

Reactions Reported After Approval
Frequency	Effect	What the labelling says
Frequency not established (commonest)	Feeling light-headed or dizzy, sedation, nausea, vomiting	Reported most often
Frequency not established	Mental clouding, lethargy, slowed thinking and movement, anxiety, fear, low or changeable mood	Nervous system and psychological effects
Frequency not established (serious)	Liver failure from acetaminophen	Linked mainly to more than 4 g a day
Frequency not established (rare, serious)	Stevens-Johnson syndrome and other severe skin reactions	Potentially fatal

Source: ¹

Seek immediate medical attention if:

Breathing becomes slow, shallow or stops
Extra tablets were taken, even if the person feels well
Skin blisters or a spreading rash appears
A child has swallowed any tablet
Severe drowsiness or confusion

Uses

What is Norco Used For?

Labelled Indication
Indication	Condition of use
Pain severe enough to require an opioid analgesic	Only when alternative treatments are inadequate

Source: ¹

The indication belongs to the generic hydrocodone-acetaminophen tablets that now fill Norco prescriptions. It is restricted because addiction, abuse, misuse, overdose and death can occur at any dose or duration; the tablets are reserved for people whose pain is not adequately managed by other options.¹

When a prescription names Norco, the pharmacist dispenses a generic product of the stated strength. Because the three generic strengths have different starting doses and daily tablet limits, the strength on the label matters more than the brand name that was written.¹⁴

Prescribers periodically reassess whether the opioid is still needed and watch for signs of misuse.¹

Safety and effectiveness in children have not been established.¹

Safety Advice

Interactions Alcohol:

Unsafe

Alcohol adds to opioid sedation and increases acetaminophen liver risk.

Interactions Other Medications:

Unsafe

CYP3A4-altering drugs, sedatives and other acetaminophen products interact seriously; see the Interactions table.

Special Groups Pregnancy:

Consult your doctor

Prolonged opioid use in pregnancy can cause neonatal opioid withdrawal syndrome.

Special Groups Breastfeeding:

Consult your doctor

Watch the infant for unusual sleepiness, breathing difficulty or limpness.

Special Groups Elderly:

Use with caution

Increased sensitivity is possible; start low.

Special Groups Children:

Consult your doctor

Safety and effectiveness in children have not been established.

Effects on Activities Driving:

Unsafe

Do not drive until you know how the medicine affects you.

Effects on Activities Operating Machinery:

Unsafe

The same applies to machinery. Liver and kidney guidance is in the Dosage section.

Warnings

Critical Warnings for Norco Use

Boxed warning

The generic tablets that replace Norco are labelled with the full set of opioid boxed warnings — misuse and addiction, dangerous slowing of breathing, deaths from accidental swallowing, withdrawal in newborns, raised hydrocodone levels with CYP3A4 inhibitors, and deep sedation with benzodiazepines or other depressants — plus a boxed warning that acetaminophen has caused acute liver failure, liver transplants and deaths.¹

Acetaminophen and the liver

Most liver injury cases followed daily intakes above 4,000 mg, frequently spread across several products.¹

Hydrocodone or acetaminophen allergy

Previous hypersensitivity to either ingredient rules the tablets out.¹

Rash

Treatment stops at the first appearance of a rash, because acetaminophen can rarely trigger fatal skin reactions.¹

Lungs and gut

The tablets are not given when breathing is already significantly depressed, during unmonitored acute or severe asthma, or when the bowel is or may be obstructed.¹

For medicines that must not be combined, see Interactions.

Dosage

Hydrocodone/APAP Tablets
Formulation	Active Ingredients	Clinical Note
5 mg/325 mg	Hydrocodone bitartrate 5 mg; acetaminophen 325 mg	Lowest strength; the brand’s 5/325 is discontinued
7.5 mg/325 mg	Hydrocodone bitartrate 7.5 mg; acetaminophen 325 mg	Generic; reference standard SpecGx
10 mg/325 mg	Hydrocodone bitartrate 10 mg; acetaminophen 325 mg	Generic; reference standard SpecGx, AA
Hepatic impairment	Hydrocodone; acetaminophen	Hydrocodone levels may be higher; start low and monitor
Renal impairment	Hydrocodone; acetaminophen	Hydrocodone levels may be higher; start low and monitor
Age 65 and over	Hydrocodone; acetaminophen	Possible increased sensitivity; start at the low end

Source: ¹⁴

Exceeding the dose

Too many tablets combine an opioid overdose, with slowed or stopped breathing, and an acetaminophen overdose, which can cause liver failure. Call emergency services immediately.¹

Interactions

What Does Norco Interact With?

Interactions by Severity
Interacting Substance	Effect and Risk	Severity	Documentation
Drugs that block CYP3A4 (e.g., macrolide antibiotics, azole antifungals, protease inhibitors)	Hydrocodone accumulates; breathing may slow dangerously	Major	Good — boxed warning
Ending a CYP3A4 inducer such as rifampin or carbamazepine	Hydrocodone exposure climbs once the inducer is gone	Major	Good — boxed warning
Additional products containing acetaminophen	Combined intake can pass the level linked to liver failure	Major	Good — boxed warning
Sleeping pills, anxiolytics, gabapentinoids, alcohol	Stacked sedation; risk of coma and death	Major	Good — observational data
Phenelzine, tranylcypromine and other MAO inhibitors	Toxic serotonergic or opioid reaction; combination advised against	Major	Fair — mechanism
SSRIs, SNRIs, tricyclics, triptans	Serotonin syndrome	Major	Fair — case reports
Buprenorphine, butorphanol, nalbuphine, pentazocine	Blocked analgesia; possible sudden withdrawal	Major	Fair — mechanism
Skeletal muscle relaxants, diuretics, anticholinergics	Deeper respiratory depression; less effective diuresis; urinary retention or ileus	Moderate	Fair — mechanism

Source: ¹

FAQs

The FDA lists all Norco strengths as discontinued. Prescriptions are filled with generic hydrocodone bitartrate and acetaminophen, and one repackager still uses the Norco name on a generic 10/325 tablet.

The generic reference tablets are rated by the FDA as therapeutically equivalent within their product group, and they contain the same two ingredients at the same strengths.

The labelling sets 8 tablets a day for 5/325 and 6 for 7.5/325 and 10/325; the higher-strength tablets carry more hydrocodone per dose.

Mainly by CYP3A4 to norhydrocodone, with a smaller share converted by CYP2D6 to hydromorphone.

Both brands combined hydrocodone with acetaminophen, but Lorcet’s listed product used a higher acetaminophen content per tablet; see the Lorcet page.

Evidence and Reported Data

Evidence Scope

What we know

The FDA records every Norco strength as discontinued, under two 1997 applications.²
SpecGx generic tablets at 5/325, 7.5/325 and 10/325 are the FDA reference standards for this combination.⁴
Hydrocodone is mostly N-demethylated by CYP3A4; CYP2D6 turns a smaller share into hydromorphone.¹

What remains uncertain

Rates of adverse reactions. Only voluntary post-approval reports are summarised.
Use under 18. Not established.
Size of the effect of liver or kidney disease. The labelling says levels may be higher but gives no figures.
What spontaneous reports can establish. Reporting is voluntary and skews toward serious, unexpected or newsworthy events, entries reach the database at least three months late, and no count of treated patients exists — so the report figures below cannot give an incidence.

Who was this medicine studied in?

No FDA Drug Trials Snapshot exists: hydrocodone-acetaminophen combinations are long-established and marketed under abbreviated applications, while Snapshots cover novel drugs approved from 2015.⁵² The labelling reports postmarketing experience without demographic breakdowns.¹

Who this is and is not appropriate for

Typically considered for: adults holding a Norco or hydrocodone-acetaminophen prescription for pain that needs an opioid, able to track acetaminophen from every source.

Not appropriate for: anyone hypersensitive to either ingredient; people whose breathing is already depressed, who have unmonitored severe asthma or a blocked bowel; and patients under 18.¹

Where to report and verify

Routing to Official Registries
What you need	Where to go
Report a side effect	FDA MedWatch
Pregnancy-specific data	MotherToBaby
Full prescribing information	DailyMed
Verify a pharmacy website	FDA BeSafeRx · LegitScript

References

FDA Prescribing Information, hydrocodone bitartrate and acetaminophen tablets USP (SpecGx, ANDA 040400, 040405, 040409) — Boxed Warning, Indications and Usage, Dosage and Administration, Contraindications, Warnings, Precautions, Adverse Reactions, Overdosage, Clinical Pharmacology, How Supplied
Label effective 2026-04-20 · Accessed 2026-09-27
Used for: the indication and limits; starting doses and daily tablet maximums by strength; boxed warnings including hepatotoxicity and CYP3A4; contraindications; skin reactions; adverse reactions; interactions; specific populations; metabolism.
dailymed.nlm.nih.gov — DailyMed
Drugs@FDA — application records for Norco (ANDA 040148, ANDA 040099) and generic hydrocodone-acetaminophen (ANDA 040400)
Records accessed 2026-09-27
Used for: the 1997 approvals and discontinued status of all Norco strengths, and the marketed generic.
accessdata.fda.gov — Drugs@FDA
FDA National Drug Code Directory — Norco listing
Directory current · Accessed 2026-09-27
Used for: the repackager listing that uses the Norco name for a generic 10/325 tablet under ANDA 040400.
accessdata.fda.gov — NDC Directory
FDA Orange Book — Approved Drug Products with Therapeutic Equivalence Evaluations, hydrocodone bitartrate and acetaminophen tablets
Current edition · Accessed 2026-09-27
Used for: the SpecGx generic tablets as reference standards and the AA rating.
accessdata.fda.gov — Orange Book
FDA — Drug Trials Snapshots programme scope
Programme current · Accessed 2026-09-27
Used for: confirmation that Snapshots cover novel drugs approved from 2015, explaining the absence of one here.
fda.gov — Drug Trials Snapshots

How this page was sourced

Because the Norco brand is discontinued, the page answers what a Norco prescription means today and uses the labelling of the current reference-standard generic tablets.

FDA adverse event aggregates are not shown for this fixed combination, because reports cannot be attributed to a combination product without misleading attribution.

Review cycle. Clinical review completed 28 September 2026. Next review due by 28 September 2027, or earlier if the labelling is revised.

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.