What is NDC 71335-1916?

71335-1916 is the product NDC for Lamivudine and Zidovudine, Lamivudine 150 mg/1; Zidovudine 300 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.

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 Lamivudine and Zidovudine?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lamivudine and Zidovudine NDC 71335-1916

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1916Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1916Add 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
71335-1916-1	71335191601	6 TABLET in 1 BOTTLE (71335-1916-1)Marketed from Jul 15, 2021
71335-1916-2	71335191602	60 TABLET in 1 BOTTLE (71335-1916-2)Marketed from Apr 5, 2024
71335-1916-3	71335191603	4 TABLET in 1 BOTTLE (71335-1916-3)Marketed from Apr 5, 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): Lamivudine and Zidovudine
Generic name (nonproprietary): lamivudine and zidovudine
Active ingredients: Lamivudine — 150 mg/1Zidovudine — 300 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 090679
Marketing start: Aug 30, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
Identifiers: Product ID 71335-1916_ae1913db-ec19-4f19-9ca8-0c524410de4cSPL ID ae1913db-ec19-4f19-9ca8-0c524410de4cSPL set ID 61d14a88-9fdf-4373-8360-44ec9e1cd350RxCUI 200082UNII 2T8Q726O95, 4B9XT59T7S
Pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

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

N471335191601 followed by a unit qualifier and the quantity

Package 71335-1916-01. 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 Apr 5, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Lamivudine and zidovudine tablets, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1916

What is NDC 71335-1916?: 71335-1916 is the product NDC for Lamivudine and Zidovudine, Lamivudine 150 mg/1; Zidovudine 300 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lamivudine and Zidovudine.
What is the active ingredient?: Lamivudine, Zidovudine.
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 Lamivudine and Zidovudine?: 7 other product NDCs are listed under this name. See all Lamivudine and Zidovudine 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 Lamivudine and Zidovudine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lamivudine And Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals, Inc	72865-144	72865-0144-60
Lamivudine and Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-003	33342-0003-09
LAMIVUDINE and ZIDOVUDINE	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-506	31722-0506-0531722-0506-60
LAMIVUDINE and ZIDOVUDINE	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-900	43063-0900-06
LAMIVUDINE and ZIDOVUDINE	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0639	71335-0639-0171335-0639-0271335-0639-03
Lamivudine and Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	Exelan Pharmaceuticals Inc.	76282-115	76282-0115-0576282-0115-60
Lamivudine and Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-739	31722-0739-0531722-0739-3131722-0739-60

Other NDCs under ANDA 090679

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

FDA NDC Directory listings under ANDA 090679
Product	Strength	Form · route	Labeler	Product NDC
Lamivudine and Zidovudine	Lamivudine 150 mg/1; Zidovudine 300 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-003