Home NDC 65862-024-45 Zidovudine
Product NDC 65862-024
Requested package NDC 65862-024-45
11-digit product format 658620024
Labeler code 65862
Product ID 65862-024_0f90ebc4-1e78-420b-a2cb-0dc715bdb853
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zidovudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077267
Marketing category ANDA
Marketing start 2005-09-19
Substance ZIDOVUDINE
Active strength 300 mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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.
Additional Listing Data#
Finished product Yes
Brand name base Zidovudine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZIDOVUDINE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4B9XT59T7S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199663 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 65862-024-10 Zidovudine 6 in 1 CARTON TABLET, FILM COATED 6 22 65862-024-10 Zidovudine 10 in 1 BLISTER PACK TABLET, FILM COATED 10 22 65862-024-60 Zidovudine 60 in 1 BOTTLE TABLET, FILM COATED 60 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 13 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZIDOVUDINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIDOVUDINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP 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 65862-024 ZIDOVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 22 Current NDC, Legacy NDC, 3 package rows 20240130_e7c8ddef-005d-4f1c-8c1a-ea84044ab4d4.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 65862-024-45 65862002445 4500 TABLET, FILM COATED in 1 BAG (65862-024-45) 19-SEP-05 Current