Hydrocodone Bitartrate and Acetaminophen NDC 50268-402

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-402Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0402Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50268-402-15	50268040215	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-402-15) / 1 TABLET in 1 BLISTER PACK (50268-402-11)Marketed from Sep 15, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Hydrocodone Bitartrate and Acetaminophen
Generic name (nonproprietary): hydrocodone bitartrate and acetaminophen
Active ingredients: Hydrocodone bitartrate — 10 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040736
Marketing start: Sep 15, 2014
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 50268-402_41b02c81-db6d-b522-e063-6394a90abb86SPL ID 41b02c81-db6d-b522-e063-6394a90abb86SPL set ID 5174bd9a-b777-a6e3-f72f-c16082ee67d3RxCUI 856999, 857002UNII NO70W886KK, 362O9ITL9D
Pharmacologic class: Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450268040215 followed by a unit qualifier and the quantity

Package 50268-0402-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 21, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone Bitartrate and Acetaminophen Tablets should not be …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040736

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040736
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	63629-5422
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-109
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-112
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	AvPAK	50268-401