Acetaminophen And Codeine Phosphate NDC 71335-1846

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1846Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1846Add 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
71335-1846-0	71335184600	100 TABLET in 1 BOTTLE (71335-1846-0)Marketed from Oct 7, 2024
71335-1846-1	71335184601	30 TABLET in 1 BOTTLE (71335-1846-1)Marketed from Jul 7, 2021
71335-1846-2	71335184602	120 TABLET in 1 BOTTLE (71335-1846-2)Marketed from Oct 7, 2024
71335-1846-3	71335184603	60 TABLET in 1 BOTTLE (71335-1846-3)Marketed from Jun 15, 2021
71335-1846-4	71335184604	90 TABLET in 1 BOTTLE (71335-1846-4)Marketed from Jun 15, 2021
71335-1846-5	71335184605	40 TABLET in 1 BOTTLE (71335-1846-5)Marketed from Oct 7, 2024
71335-1846-6	71335184606	20 TABLET in 1 BOTTLE (71335-1846-6)Marketed from Oct 7, 2024
71335-1846-7	71335184607	112 TABLET in 1 BOTTLE (71335-1846-7)Marketed from Oct 7, 2024
71335-1846-8	71335184608	84 TABLET in 1 BOTTLE (71335-1846-8)Marketed from Oct 7, 2024
71335-1846-9	71335184609	15 TABLET in 1 BOTTLE (71335-1846-9)Marketed from Oct 7, 2024

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 Phosphate
Generic name (nonproprietary): acetaminophen and codeine phosphate
Active ingredients: Acetaminophen — 300 mg/1Codeine phosphate — 60 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 211610
Marketing start: Aug 2, 2019
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71335-1846_6c7258ab-22b9-49e0-b78c-46732502c212SPL ID 6c7258ab-22b9-49e0-b78c-46732502c212SPL set ID ff77a959-c77a-4911-8f7c-e2a3e24a6305RxCUI 993890UNII 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

N471335184600 followed by a unit qualifier and the quantity

Package 71335-1846-00. 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 15, 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 phosphat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211610

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

FDA NDC Directory listings under ANDA 211610
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-1818
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3651
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3658
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Bryant Ranch Prepack	63629-1190
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8882
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Redpharm Drug	67296-2239
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Bryant Ranch Prepack	72162-2002
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	72162-2001
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Asclemed USA, Inc.	76420-821
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	REMEDYREPACK INC.	70518-2628
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	REMEDYREPACK INC.	70518-2764
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Eywa Pharma Inc	71930-056
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1	TabletOral	Eywa Pharma Inc	71930-054
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Eywa Pharma Inc	71930-055