Lamivudine

Product NDC
65862-552
11-digit product format
658620552
Labeler code
65862
Product ID
65862-552_199cd88b-1136-4ac0-a58d-81ea700ce718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202032
Marketing category
ANDA
Marketing start
2011-11-17
Marketing end
0000-00-00
Substance
LAMIVUDINE
Active strength
150 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]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65862-552DDiscontinued by firm2026-10-15
excluded packagepackage65862-55265862-552-10DDiscontinued by firm2026-10-15
excluded packagepackage65862-55265862-552-60DDiscontinued by firm2026-10-15

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65862-552-10DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65862-552-60DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-552-26UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-552-26UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-552-26UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-552-26UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-552-26UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-552-26UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202032-001LAMIVUDINELAMIVUDINE150MGTABLET / ORAL2011-11-17
A202032-002LAMIVUDINELAMIVUDINE300MGTABLET / ORAL2011-11-17

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-17c2088c7a36db…
2026-10-15 13:18:302026-09A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-17c2088c7a36db…
2026-09-14 22:38:342026-08A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-1784e616aacf4f…
2026-09-14 22:38:342026-08A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-1784e616aacf4f…
2026-08-18 06:07:402026-07A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202032-001LAMIVUDINE150MGTABLET / ORAL2011-11-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202032-002LAMIVUDINE300MGTABLET / ORAL2011-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202032-001LAMIVUDINE150MGTABLET / ORALAB2011-11-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202032-002LAMIVUDINE300MGTABLET / ORALAB2011-11-174b0b4de00fa7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04A202032-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202032-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202032-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202032-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202032-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202032-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202032-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202032-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202032-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202032-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202032-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A202032-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202032-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202032-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202032-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202032-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202032-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A202032-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202032-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202032-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202032-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202032-002AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-552-60EA - Each65862-5525c296034-e20b-42ec-ad6c-165fc42b2cbe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95LAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
LAMIVUDINEACTIVE MOIETY2T8Q726O95LAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMIVUDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-552-10658620552106 BLISTER PACK in 1 CARTON (65862-552-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2011-11-170000-00-00NoNoCurrent
65862-552-606586205526060 TABLET, FILM COATED in 1 BOTTLE (65862-552-60) 2011-11-170000-00-00NoNoCurrent