zidovudine

Product NDC
53104-0105
11-digit product format
531040105
Labeler code
53104
Product ID
53104-0105_e94ab1eb-51f3-4cb0-a4de-f3b93d3943b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zidovudine
Dosage form
SYRUP
Route
ORAL
Labeler
Cipla Ltd.
Application
ANDA077981
Marketing category
ANDA
Marketing start
2008-06-26
Marketing end
0000-00-00
Substance
ZIDOVUDINE
Active strength
50 mg/5mL
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53104-0105IInactivated by FDA2026-08-17
excluded packagepackage53104-010553104-0105-9IInactivated by FDA2026-08-17

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53104-0105-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53104-0105-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53104-0105-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53104-0105-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53104-0105-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53104-0105-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53104-0105-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53104-0105-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53104-0105-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53104-0105-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53104-0105-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53104-0105-9557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53104-0105-98af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53104-0105-9834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53104-0105-91332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53104-0105-9fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53104-0105-986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53104-0105-9bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53104-0105-98dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53104-0105-9e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53104-0105-99bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077981-001ZIDOVUDINEZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077981-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077981-001ZIDOVUDINE50MG/5MLSYRUP / ORALAA2008-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077981-001ZIDOVUDINE50MG/5MLSYRUP / ORALAA2008-06-263f01610625f2…
2019-09-15 20:21 UTC2019-09A077981-001ZIDOVUDINE50MG/5MLSYRUP / ORALAA2008-06-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A077981-001ZIDOVUDINE50MG/5MLSYRUP / ORALAA2008-06-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077981-001ZIDOVUDINE50MG/5MLSOLUTION / ORALAA2008-06-26e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077981-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077981-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077981-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077981-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077981-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077981-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077981-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077981-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077981-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077981-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077981-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077981-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077981-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077981-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077981-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077981-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077981-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077981-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077981-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077981-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077981-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077981-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A077981-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077981-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077981-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077981-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A077981-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077981-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077981-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077981-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077981-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077981-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077981-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077981-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077981-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077981-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077981-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077981-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077981-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077981-001AA1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fbdbfbef-2c33-0298-4fef-f6693e670fe1Product name720181210
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
e1098f43-eafb-82a0-ef30-575f1d8189b0Product name220150227
9ceb457b-0c09-9326-bbca-f296202d412cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53104-0105-9zidovudine240 mL in 1 BOTTLESYRUP24018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZIDOVUDINEACTIVE INGREDIENT4B9XT59T7SZIDOVUDINE SYRUP [CIPLA LTD.]11
ZIDOVUDINEACTIVE MOIETY4B9XT59T7SZIDOVUDINE SYRUP [CIPLA LTD.]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZIDOVUDINE SYRUP [CIPLA LTD.]11
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZIDOVUDINE SYRUP [CIPLA LTD.]11
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUZIDOVUDINE SYRUP [CIPLA LTD.]11
SUCROSEINACTIVE INGREDIENTC151H8M554ZIDOVUDINE SYRUP [CIPLA LTD.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53104-0105ZIDOVUDINE SYRUP [CIPLA LTD.]18Legacy NDC, 1 package rows20181218_e62ae0e4-0689-431a-a552-f0711ca68844.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756209zidovudine 10 MG in 1 mL Oral SolutionPSNe62ae0e4-0689-431a-a552-f0711ca6884418
756209zidovudine 10 MG/ML Oral SolutionSCDe62ae0e4-0689-431a-a552-f0711ca6884418
756209AZT 10 MG/ML Oral SolutionSYe62ae0e4-0689-431a-a552-f0711ca6884418
756209zidovudine 10 MG per 1 ML Oral SolutionSYe62ae0e4-0689-431a-a552-f0711ca6884418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53104-0105-953104010509240 mL in 1 BOTTLE240 mlHistorical