Home NDC 65862-048 Zidovudine
Product NDC 65862-048
11-digit product format 658620048
Labeler code 65862
Product ID 65862-048_19584bb3-e849-4839-961f-c38bb07a4e8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zidovudine
Dosage form SYRUP
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077268
Marketing category ANDA
Marketing start 2005-09-19
Substance ZIDOVUDINE
Active strength 10 mg/mL
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 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 A077268-001 ZIDOVUDINE ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 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 A077268-001 AA
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 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077268-001 ZIDOVUDINE 50MG/5ML SYRUP / ORAL AA 2005-09-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077268-001 ZIDOVUDINE 50MG/5ML SYRUP / ORAL AA 2005-09-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077268-001 ZIDOVUDINE 50MG/5ML SYRUP / ORAL AA 2005-09-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077268-001 ZIDOVUDINE 50MG/5ML SYRUP / ORAL AA 2005-09-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 2005-09-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077268-001 ZIDOVUDINE 50MG/5ML SOLUTION / ORAL AA 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 10 mg/mL
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 756209 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 65862-048-24 Zidovudine 240 mL in 1 BOTTLE SYRUP 240 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-048 ZIDOVUDINE SYRUP [AUROBINDO PHARMA LIMITED] 22 Current NDC, Legacy NDC, 1 package rows 20250216_51abd2ce-6be1-412d-b806-5f24935ac5e3.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 Units Marketing start Marketing end Sample Exclude flag Status 65862-048-24 65862004824 240 mL in 1 BOTTLE (65862-048-24) 240 ml 2005-09-19 0000-00-00 No No Current