Home NDC 49702-202 COMBIVIR
Product NDC 49702-202
11-digit product format 497020202
Labeler code 49702
Product ID 49702-202_42a6587e-9322-4810-8c72-1dc40f3543d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamivudine and zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ViiV Healthcare Company
Application NDA020857
Marketing category NDA
Marketing start 2010-10-19
Marketing end 2027-02-28
Substance LAMIVUDINE; ZIDOVUDINE
Active strength 150; 300 mg/1; mg/1
Pharmacologic classes 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]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020857-001 COMBIVIR LAMIVUDINE; ZIDOVUDINE 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base COMBIVIR Active Ingredients# Ingredient, Strength table Ingredient Strength LAMIVUDINE 150 mg/1 ZIDOVUDINE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2T8Q726O95 Internal UNII lookup 4B9XT59T7S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200082 Internal RxNorm lookup 213088 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49702-202-18 COMBIVIR 60 in 1 BOTTLE TABLET, FILM COATED 60 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 10 LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-202 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY] 22 Current NDC, Legacy NDC, 1 package rows 20241003_16da660b-9981-4d24-a14a-94c7744fce4f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COMBIVIR LAMIVUDINE AND ZIDOVUDINE ViiV Healthcare Company 16da660b-9981-4d24-a14a-94c7744fce4f 2023-08-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020857 application number: NDA020857 ndc (product): 49702-202
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49702-202-18 49702020218 60 TABLET, FILM COATED in 1 BOTTLE (49702-202-18) 2010-10-19 2027-02-28 No No Current