Quick answers
- What is Hydrocodone bitartrate and acetaminophen used for?
- The FDA-approved label (Norco, Direct_Rx, January 22, 2025) says: “Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydrocodone bitartrate and acetaminophen have a boxed warning?
- Yes. The FDA label for Norco has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Hydrocodone bitartrate and acetaminophen?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hydrocodone bitartrate and acetaminophen been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 19, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Hydrocodone bitartrate and acetaminophen?
- 33 companies list prescription products of Hydrocodone bitartrate and acetaminophen in the FDA NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc. and Proficient Rx LP.
What Hydrocodone bitartrate and acetaminophen is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative …
— FDA label: Norco, Direct_Rx, effective January 22, 2025. Read the full label on DailyMed →
The FDA has 150 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
147 of 150 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Solution · Liquid |
|---|---|
| Route | Oral |
| Prescription products | 208 in the FDA NDC Directory |
| Brand names | Norco |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| acetaminophen 300 mg · hydrocodone bitartrate 10 mg tablet | Generic | $0.2599 per tablet |
| acetaminophen 300 mg · hydrocodone bitartrate 5 mg tablet | Generic | $0.1875 per tablet |
| acetaminophen 300 mg · hydrocodone bitartrate 7.5 mg tablet | Generic | $0.2412 per tablet |
| acetaminophen 325 mg · hydrocodone bitartrate 10 mg tablet | Generic | $0.1484 per tablet |
| acetaminophen 325 mg · hydrocodone bitartrate 5 mg tablet | Generic | $0.1320 per tablet |
| acetaminophen 325 mg · hydrocodone bitartrate 7.5 mg tablet | Generic | $0.1306 per tablet |
| acetaminophen 325 mg/15 mL · hydrocodone bitartrate 7.5 mg/15 mL solution | Generic | $0.2435 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack74 products
- Asclemed USA, Inc.9 products
- Proficient Rx LP9 products
- XLCare Pharmaceuticals, Inc.8 products
- Cranbury Pharmaceuticals, LLC8 products
- NuCare Pharmaceuticals, Inc.8 products
- Eywa Pharma Inc7 products
- Direct_Rx7 products
- SpecGx LLC6 products
- KVK-Tech, Inc.6 products
- Lupin Pharmaceuticals, Inc.6 products
- Aurolife Pharma, LLC6 products
- St. Mary's Medical Park Pharmacy5 products
- Camber Pharmaceuticals, Inc.4 products
- Elite Laboratories, Inc.4 products
- American Health Packaging4 products
- AvPAK3 products
- Rhodes Pharmaceuticals LLC3 products
- Upsher-Smith Laboratories, LLC3 products
- Strides Pharma Science Limited3 products
- Granules Pharmaceuticals Inc.3 products
- Epic Pharma, LLC3 products
- PAI Holdings, LLC dba PAI Pharma3 products
- Redpharm Drug3 products
- DirectRx2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Quality Care Products, LLC2 products
- Genus Lifesciences Inc.2 products
- Golden State Medical Supply, Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- A-S Medication Solutions1 product
- RedPharm Drug, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (27)
- ANDA040400Specgx LLC · July 26, 2000
- ANDA040405Specgx LLC · September 8, 2000
- ANDA040409Specgx LLC · October 20, 2000
- ANDA040736Amneal Pharms Ny · August 25, 2006
- ANDA040746Amneal Pharms Ny · August 25, 2006
- ANDA040881Pharmobedient · February 25, 2010
- ANDA040894Genus · July 19, 2011
- ANDA201013Aurolife Pharma LLC · April 11, 2012
- ANDA202214Tris Pharma Inc · March 27, 2013
- ANDA040838Pharm Assoc · May 10, 2013
- ANDA202991Rhodes Pharms · April 12, 2016
- ANDA202935Strides Pharma Intl · June 15, 2016
- ANDA206142Novel Labs Inc · November 14, 2016
- ANDA206245Novel Labs Inc · December 1, 2016
- ANDA206484Upsher Smith Labs · March 24, 2017
- ANDA206718Specgx LLC · March 31, 2017
- ANDA209036Abhai LLC · June 21, 2017
- ANDA209037Abhai LLC · June 21, 2017
- ANDA210211Wes Pharma Inc · October 30, 2017
- ANDA203863Epic Pharma LLC · March 30, 2018
- ANDA207709Aurolife Pharma LLC · September 13, 2018
- ANDA207509Adaptis · October 29, 2018
- ANDA211487Ascent Pharms Inc · November 7, 2018
- ANDA209924Elite Labs Inc · November 16, 2018
- ANDA211023Wes Pharma Inc · March 8, 2019
- ANDA211729Granules · January 3, 2020
- ANDA201295Tris Pharma Inc · December 30, 2021
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 19, 2021 · Class II · Terminated · D-0276-2022
Product Mix-up
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central I — Ascent Pharmaceuticals, Inc.
-
May 24, 2018 · Class III · Terminated · D-0836-2018
Labeling: Missing Label
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 — LUPIN SOMERSET
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Norco, Direct_Rx, effective January 22, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →