Acetaminophen and Codeine NDC 67296-1772

NDC codes

FDA NDC Directory

Product NDC (as listed)67296-1772Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67296-1772Add 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
67296-1772-1	67296177201	10 TABLET in 1 BOTTLE (67296-1772-1)Marketed from Jan 1, 2020
67296-1772-5	67296177205	15 TABLET in 1 BOTTLE, PLASTIC (67296-1772-5)Marketed from Jan 1, 2020
67296-1772-6	67296177206	6 TABLET in 1 BOTTLE (67296-1772-6)Marketed from Jan 1, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Acetaminophen and Codeine
Generic name (nonproprietary): acetaminophen and codeine
Active ingredients: Acetaminophen — 300 mg/1Codeine phosphate — 30 mg/1
Dosage form: Tablet
Route: Oral
Labeler: RedPharm Drug, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040779
Marketing start: Jan 1, 2020
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 67296-1772_3253a2e4-0bc4-4ce7-e063-6294a90a6c51SPL ID 3253a2e4-0bc4-4ce7-e063-6294a90a6c51SPL set ID a35b4ba3-43c0-73c8-e053-2a95a90af5b5RxCUI 993781UNII 362O9ITL9D, GSL05Y1MN6UPC 0365162033106, 0367296177268
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

N467296177201 followed by a unit qualifier and the quantity

Package 67296-1772-01. 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 Apr 9, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). Have not provided adequate analgesia, or are not expected to provide adequate analgesia, Have not been tolerated, or are not expected to be tolerated.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040779

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

FDA NDC Directory listings under ANDA 040779
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-0545
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-033
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Proficient Rx LP	63187-491
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Asclemed USA, Inc.	76420-103