Lamivudine and Zidovudine

Product NDC
54741-102
11-digit product format
547410102
Labeler code
54741
Product ID
54741-102_f1a8c545-1a17-4034-9fb4-fd5d468032db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine and zidovudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Shanghai Desano Bio-Pharmaceutical Co., Ltd.
Application
ANDA206375
Marketing category
ANDA
Marketing start
2018-04-19
Marketing end
0000-00-00
Substance
LAMIVUDINE; ZIDOVUDINE
Active strength
150 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],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 productproduct54741-102IInactivated by FDA2026-08-03
excluded packagepackage54741-10254741-102-01IInactivated by FDA2026-08-03

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 packagepackage54741-102-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54741-102-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54741-102-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54741-102-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54741-102-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54741-102-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54741-102-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54741-102-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54741-102-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54741-102-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54741-102-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54741-102-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54741-102-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54741-102-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54741-102-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54741-102-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54741-102-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54741-102-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54741-102-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54741-102-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54741-102-019bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206375-001LAMIVUDINE AND ZIDOVUDINELAMIVUDINE; ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206375-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-103f01610625f2…
2019-09-15 20:21 UTC2019-09A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206375-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORALAB2018-04-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206375-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206375-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206375-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206375-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206375-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206375-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206375-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206375-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206375-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206375-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206375-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206375-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206375-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206375-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206375-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206375-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206375-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206375-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206375-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206375-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206375-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206375-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206375-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206375-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206375-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206375-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206375-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206375-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206375-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206375-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206375-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206375-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206375-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206375-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206375-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206375-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206375-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206375-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206375-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206375-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aaa99659-c62c-7281-d402-9590409850c2Product name620260128
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8eProduct name820250626
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
3832141c-c294-474a-9473-1052c891450eProduct name220230105
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47eProduct name120190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68Product name320190627
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1Product name720181210
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
af19b329-4f44-cd81-491a-fbb7fe7a079fProduct name220151013
c873f14e-2add-4d53-b9b3-bf775efd3702Product name120150325
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
54741-102-01Lamivudine and Zidovudine60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54741-102LAMIVUDINE AND ZIDOVUDINE TABLET, FILM COATED [SHANGHAI DESANO BIO-PHARMACEUTICAL CO., LTD.]2Legacy NDC, 1 package rows20180524_97f25ee5-aa70-4f7a-b710-50b56e5de135.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200082lamiVUDine 150 MG / zidovudine 300 MG Oral TabletPSN97f25ee5-aa70-4f7a-b710-50b56e5de1352
200082lamivudine 150 MG / zidovudine 300 MG Oral TabletSCD97f25ee5-aa70-4f7a-b710-50b56e5de1352
2000823TC 150 MG / AZT 300 MG Oral TabletSY97f25ee5-aa70-4f7a-b710-50b56e5de1352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54741-102-015474101020160 in 1 BOTTLEHistorical