Home NDC 52959-546 COMBIVIR
Product NDC 52959-546
11-digit product format 529590546
Labeler code 52959
Product ID 52959-546_37641156-8d51-4e36-abb6-b46cb9e7f828
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamivudine and zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application NDA020857
Marketing category NDA
Marketing start 2010-10-19
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 5 · 242 matching rows.
View current auxiliary records. · View the auxiliary file history.
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COMBIVIR LAMIVUDINE; ZIDOVUDINE 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26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 52959-546-02 COMBIVIR 2 in 1 BOTTLE TABLET, FILM COATED 2 1 52959-546-03 COMBIVIR 3 in 1 BOTTLE TABLET, FILM COATED 3 1 52959-546-04 COMBIVIR 4 in 1 BOTTLE TABLET, FILM COATED 4 1 52959-546-06 COMBIVIR 6 in 1 BOTTLE TABLET, FILM COATED 6 1 52959-546-08 COMBIVIR 8 in 1 BOTTLE TABLET, FILM COATED 8 1 52959-546-10 COMBIVIR 10 in 1 BOTTLE TABLET, FILM COATED 10 1 52959-546-14 COMBIVIR 14 in 1 BOTTLE TABLET, FILM COATED 14 1 52959-546-15 COMBIVIR 15 in 1 BOTTLE TABLET, FILM COATED 15 1 52959-546-20 COMBIVIR 20 in 1 BOTTLE TABLET, FILM COATED 20 1 52959-546-28 COMBIVIR 28 in 1 BOTTLE TABLET, FILM COATED 28 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 [H.J. HARKINS COMPANY, INC.] 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 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 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 [H.J. HARKINS COMPANY, INC.] 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 [H.J. HARKINS COMPANY, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A 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 [H.J. HARKINS COMPANY, INC.] 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
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-546 COMBIVIR (LAMIVUDINE AND ZIDOVUDINE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 Legacy NDC, 10 package rows 20120215_479a2784-8db2-4fe5-94ba-55316a3c4e4f.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 52959-546-02 52959054602 2 in 1 BOTTLE Historical 52959-546-03 52959054603 3 in 1 BOTTLE Historical 52959-546-04 52959054604 4 in 1 BOTTLE Historical 52959-546-06 52959054606 6 in 1 BOTTLE Historical 52959-546-08 52959054608 8 in 1 BOTTLE Historical 52959-546-10 52959054610 10 in 1 BOTTLE Historical 52959-546-14 52959054614 14 in 1 BOTTLE Historical 52959-546-15 52959054615 15 in 1 BOTTLE Historical 52959-546-20 52959054620 20 in 1 BOTTLE Historical 52959-546-28 52959054628 28 in 1 BOTTLE Historical