Acetaminophen and Codeine Phosphate NDC 64950-374

NDC codes

FDA NDC Directory

Product NDC (as listed)64950-374Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64950-0374Add 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
64950-374-04	64950037404	118 mL in 1 BOTTLE, PLASTIC (64950-374-04)Marketed from Aug 10, 2023
64950-374-16	64950037416	473 mL in 1 BOTTLE, PLASTIC (64950-374-16)Marketed from Aug 10, 2023

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): Acetaminophen and Codeine Phosphate
Generic name (nonproprietary): acetaminophen and codeine phosphate
Active ingredients: Acetaminophen — 120 mg/5mLCodeine phosphate — 12 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Genus Lifesciences Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 087508
Marketing start: Aug 10, 2023
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 64950-374_87cb7b3c-3ed5-4a40-a486-7713bb2b6e3eSPL ID 87cb7b3c-3ed5-4a40-a486-7713bb2b6e3eSPL set ID 95a5d638-3072-4c37-a4cd-f8550328e2c6RxCUI 993755UNII 362O9ITL9D, GSL05Y1MN6
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

N464950037404 followed by a unit qualifier and the quantity

Package 64950-0374-04. 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 Feb 25, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Acetaminophen and codeine phosphate oral solution is 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ] , reserve opioid analgesics, including acetaminophen and codeine phosphate oral solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 087508

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

FDA NDC Directory listings under ANDA 087508
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/12.5mL; Codeine phosphate 30 mg/12.5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1008
Acetaminophen and Codeine Phosphate	Acetaminophen 120 mg/5mL; Codeine phosphate 12 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0504