Acetaminophen and Codeine NDC 71335-0545

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0545Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0545Add 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
71335-0545-0	71335054500	40 TABLET in 1 BOTTLE (71335-0545-0)Marketed from May 11, 2018
71335-0545-1	71335054501	6 TABLET in 1 BOTTLE (71335-0545-1)Marketed from May 1, 2018
71335-0545-2	71335054502	20 TABLET in 1 BOTTLE (71335-0545-2)Marketed from May 1, 2018
71335-0545-3	71335054503	30 TABLET in 1 BOTTLE (71335-0545-3)Marketed from May 11, 2018
71335-0545-4	71335054504	84 TABLET in 1 BOTTLE (71335-0545-4)Marketed from May 11, 2018
71335-0545-5	71335054505	15 TABLET in 1 BOTTLE (71335-0545-5)Marketed from May 11, 2018
71335-0545-6	71335054506	120 TABLET in 1 BOTTLE (71335-0545-6)Marketed from May 11, 2018
71335-0545-7	71335054507	100 TABLET in 1 BOTTLE (71335-0545-7)Marketed from May 11, 2018
71335-0545-8	71335054508	60 TABLET in 1 BOTTLE (71335-0545-8)Marketed from May 11, 2018
71335-0545-9	71335054509	90 TABLET in 1 BOTTLE (71335-0545-9)Marketed from May 11, 2018

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: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040779
Marketing start: May 29, 2008
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71335-0545_807a4459-2481-4325-a73e-a1e6bff4d5c0SPL ID 807a4459-2481-4325-a73e-a1e6bff4d5c0SPL set ID 7d940b9c-7406-4182-9052-c6a5806337a0RxCUI 993781UNII 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

N471335054500 followed by a unit qualifier and the quantity

Package 71335-0545-00. 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 May 6, 2026. 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, which can occur at any dosage or duration (see WARNINGS ), reserve acetaminophen and codeine phosphate 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. Acetaminophen and codeine phosphate tabl…

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	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
Acetaminophen and Codeine	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	RedPharm Drug, Inc.	67296-1772