lamivudine and zidovudine

Generic: lamivudine and zidovudine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamivudine and zidovudine
Generic Name lamivudine and zidovudine
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lamivudine 150 mg/1, zidovudine 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0639
Product ID 71335-0639_aa348cf2-2e1b-486f-9bec-5ccf67879175
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079124
Listing Expiration 2026-12-31
Marketing Start 2015-09-18

Pharmacologic Class

Established (EPC)
hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713350639
Hyphenated Format 71335-0639

Supplemental Identifiers

RxCUI
200082
UNII
2T8Q726O95 4B9XT59T7S
NUI
N0000175656 N0000175462 N0000009947

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lamivudine and zidovudine (source: ndc)
Generic Name lamivudine and zidovudine (source: ndc)
Application Number ANDA079124 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE (71335-0639-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-0639-2)
  • 4 TABLET, FILM COATED in 1 BOTTLE (71335-0639-3)
source: ndc

Packages (3)

71335-0639-1 6 TABLET, FILM COATED in 1 BOTTLE (71335-0639-1) 71335-0639-2 60 TABLET, FILM COATED in 1 BOTTLE (71335-0639-2) 71335-0639-3 4 TABLET, FILM COATED in 1 BOTTLE (71335-0639-3)

Ingredients (2)

lamivudine (150 mg/1) zidovudine (300 mg/1)

Linked Drug Pages (1)

LAMIVUDINE and ZIDOVUDINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aa348cf2-2e1b-486f-9bec-5ccf67879175", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["2T8Q726O95", "4B9XT59T7S"], "rxcui": ["200082"], "spl_set_id": ["005f1b9d-1950-4ef3-a9d6-c428a40a3630"], "pharm_class_epc": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (71335-0639-1)", "package_ndc": "71335-0639-1", "marketing_start_date": "20210402"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0639-2)", "package_ndc": "71335-0639-2", "marketing_start_date": "20211227"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (71335-0639-3)", "package_ndc": "71335-0639-3", "marketing_start_date": "20211227"}], "brand_name": "LAMIVUDINE and ZIDOVUDINE", "product_id": "71335-0639_aa348cf2-2e1b-486f-9bec-5ccf67879175", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "71335-0639", "generic_name": "LAMIVUDINE and ZIDOVUDINE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAMIVUDINE and ZIDOVUDINE", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "150 mg/1"}, {"name": "ZIDOVUDINE", "strength": "300 mg/1"}], "application_number": "ANDA079124", "marketing_category": "ANDA", "marketing_start_date": "20150918", "listing_expiration_date": "20261231"}