Home NDC 67046-1613 Zidovudine
Product NDC 67046-1613
11-digit product format 670461613
Labeler code 67046
Product ID 67046-1613_48c0ccac-2fe3-0fe2-e063-6294a90a2a9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zidovudine
Dosage form TABLET
Route ORAL
Labeler Coupler LLC
Application ANDA090092
Marketing category ANDA
Marketing start 2025-11-13
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 2027-12-31
Current FDA listing Yes 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 A090092-001 ZIDOVUDINE ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090092-001 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 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090092-001 ZIDOVUDINE 300MG TABLET / ORAL AB RS 2008-04-25 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 2027-12-31 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 67046-1613-3 Zidovudine 30 in 1 BLISTER PACK TABLET 30 2
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67046-1613-3 67046161303 30 TABLET in 1 BLISTER PACK (67046-1613-3) 30 tablet 2025-11-13 No No Current