Home NDC 52343-045 Zidovudine
Product NDC 52343-045
11-digit product format 523430045
Labeler code 52343
Product ID 52343-045_966ff559-1260-42c5-8030-f306e5c45f1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ACETRIS HEALTH, LLC
Application ANDA077267
Marketing category ANDA
Marketing start 2005-09-19
Marketing end 0000-00-00
Substance ZIDOVUDINE
Active strength 300 mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 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 52343-045-60 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077267-001 ZIDOVUDINE ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077267-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077267-001 ZIDOVUDINE 300MG TABLET / ORAL AB 2005-09-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIDOVUDINE TABLET, FILM COATED [GEN-SOURCE RX] 1
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 Zidovudine ZIDOVUDINE Aurobindo Pharma Limited e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4 2024-01-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077267 application number: ANDA077267
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52343-045-60 52343004560 60 TABLET, FILM COATED in 1 BOTTLE (52343-045-60) 2005-09-19 0000-00-00 No No Current