What is NDC 71335-0336?

71335-0336 is the product NDC for Acetaminophen and Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Acetaminophen, Codeine phosphate.

Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acetaminophen and Codeine Phosphate?

67 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acetaminophen and Codeine Phosphate NDC 71335-0336

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0336Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0336Add 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
71335-0336-0	71335033600	100 TABLET in 1 BOTTLE (71335-0336-0)Marketed from Aug 9, 2024
71335-0336-1	71335033601	30 TABLET in 1 BOTTLE (71335-0336-1)Marketed from May 9, 2018
71335-0336-2	71335033602	120 TABLET in 1 BOTTLE (71335-0336-2)Marketed from Aug 9, 2024
71335-0336-3	71335033603	60 TABLET in 1 BOTTLE (71335-0336-3)Marketed from Feb 12, 2018
71335-0336-4	71335033604	90 TABLET in 1 BOTTLE (71335-0336-4)Marketed from Aug 9, 2024
71335-0336-5	71335033605	40 TABLET in 1 BOTTLE (71335-0336-5)Marketed from Aug 9, 2024
71335-0336-6	71335033606	20 TABLET in 1 BOTTLE (71335-0336-6)Marketed from Mar 29, 2018
71335-0336-7	71335033607	112 TABLET in 1 BOTTLE (71335-0336-7)Marketed from Aug 9, 2024
71335-0336-8	71335033608	84 TABLET in 1 BOTTLE (71335-0336-8)Marketed from Aug 9, 2024
71335-0336-9	71335033609	15 TABLET in 1 BOTTLE (71335-0336-9)Marketed from Aug 9, 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 PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202800
Marketing start: Apr 15, 2013
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71335-0336_dd27c850-8f70-4492-9a8c-9610b5ff58d2SPL ID dd27c850-8f70-4492-9a8c-9610b5ff58d2SPL set ID 9f2127d9-d60b-42d3-9b6c-798e63dd68d1RxCUI 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

N471335033600 followed by a unit qualifier and the quantity

Package 71335-0336-00. 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 Aug 9, 2024. 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 t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0336

What is NDC 71335-0336?: 71335-0336 is the product NDC for Acetaminophen and Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen and Codeine Phosphate.
What is the active ingredient?: Acetaminophen, Codeine phosphate.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetaminophen and Codeine Phosphate?: 67 other product NDCs are listed under this name. See all Acetaminophen and Codeine Phosphate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Acetaminophen and Codeine Phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-009	87441-0009-01
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8881	68788-8881-0168788-8881-0368788-8881-06
Acetaminophen And Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8882	68788-8882-0168788-8882-0368788-8882-06
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0527	80425-0527-0180425-0527-0280425-0527-03
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0528	80425-0528-0180425-0528-0280425-0528-03
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0529	80425-0529-0180425-0529-0280425-0529-03
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0530	80425-0530-0180425-0530-0280425-0530-03
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	REMEDYREPACK INC.	70518-4104	70518-4104-00
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-938	60760-0938-30
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Strides Pharma Science Limited	64380-446	64380-0446-0164380-0446-0264380-0446-03

All 68 Acetaminophen and Codeine Phosphate NDCs

Other NDCs under ANDA 202800

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

FDA NDC Directory listings under ANDA 202800
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1	TabletOral	Aurolife Pharma, LLC	13107-058
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Aurolife Pharma, LLC	13107-059
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	Aurolife Pharma, LLC	13107-060
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Proficient Rx LP	63187-815
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4673
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4749
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5010
Acetaminophen and Codeine Phosphate	Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-0256