Home NDC 21695-846 COMBIVIR
Product NDC 21695-846
11-digit product format 216950846
Labeler code 21695
Product ID 21695-846_d8540843-055c-47fb-9cff-81e64b1d41c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamivudine and zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application NDA020857
Marketing category NDA
Marketing start 1997-09-30
Marketing end 0000-00-00
Substance LAMIVUDINE; ZIDOVUDINE
Active strength 150 mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 21695-846-06 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 21695-846-06 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 21695-846-06 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 21695-846-06 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 21695-846-06 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 21695-846-06 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 21695-846-06 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 21695-846-06 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 21695-846-06 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 21695-846-06 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 21695-846-06 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 21695-846-06 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 21695-846-06 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 21695-846-06 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 21695-846-06 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 21695-846-06 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 21695-846-06 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 21695-846-06 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 21695-846-06 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 21695-846-06 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 21695-846-06 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 21695-846-06 110d247fa046…a55b01930146…
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# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-846-06 COMBIVIR 6 in 1 BOTTLE TABLET, FILM COATED 6 1
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 [REBEL DISTRIBUTORS CORP] 1 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-846 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 1 package rows 20101126_d8540843-055c-47fb-9cff-81e64b1d41c3.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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-846-06 21695084606 6 in 1 BOTTLE Historical