Acetaminophen and Codeine Phosphate NDC 0121-0504

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0504Add 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
0121-0504-40	00121050440	40 TRAY in 1 CASE (0121-0504-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0504-05)Marketed from Aug 21, 1981

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: PAI Holdings, LLC dba PAI Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 087508
Marketing start: Aug 21, 1981
Listing expires: Dec 31, 2027
DEA schedule: CV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0121-0504_6f1542c8-c4b9-438d-a6f7-6f5daa87a286SPL ID 6f1542c8-c4b9-438d-a6f7-6f5daa87a286SPL set ID 95ac6875-6b14-4cde-8efb-80704e39b8d8RxCUI 993755UNII GSL05Y1MN6, 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

N400121050440 followed by a unit qualifier and the quantity

Package 00121-0504-40. 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 Aug 6, 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	Genus Lifesciences Inc.	64950-374