EPIVIR

Product NDC
53808-0246
11-digit product format
538080246
Labeler code
53808
Product ID
53808-0246_4e2ee289-a8d8-4d02-ac27-0a2a2d0bbe22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020564
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
LAMIVUDINE
Active strength
300 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
E
Listing certified through
2017-12-31
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 productproduct53808-0246IInactivated by FDA2026-10-05
excluded packagepackage53808-024653808-0246-1IInactivated by FDA2026-10-05

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 · 44 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 packagepackage53808-0246-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0246-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0246-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0246-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0246-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0246-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0246-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0246-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0246-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0246-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0246-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0246-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0246-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0246-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0246-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0246-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0246-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0246-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0246-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0246-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0246-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0246-1110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020564-001EPIVIRLAMIVUDINE150MGTABLET / ORALABRLD1995-11-17
N020564-003EPIVIRLAMIVUDINE300MGTABLET / ORALABRLD, RS2002-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020564-001AB
N020564-003AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-1784e616aacf4f…
2026-09-14 22:38:342026-08N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-2484e616aacf4f…
2026-08-18 06:07:402026-07N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020564-001EPIVIR150MGTABLET / ORALABRLD1995-11-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020564-003EPIVIR300MGTABLET / ORALABRLD, RS2002-06-2474a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020564-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020564-003AB184e616aacf4f…
2026-08-18 06:07:402026-07N020564-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020564-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020564-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020564-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020564-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020564-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020564-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020564-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020564-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020564-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020564-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020564-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020564-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020564-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020564-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020564-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020564-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020564-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020564-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020564-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020564-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020564-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020564-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020564-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020564-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020564-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020564-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020564-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020564-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020564-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020564-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020564-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020564-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020564-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020564-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020564-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020564-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020564-003AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0246-1EPIVIR30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0246EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100526_13ca868d-a734-4c2f-88f0-ac1071ba7311.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
152931Epivir 150 MG Oral TabletPSN13ca868d-a734-4c2f-88f0-ac1071ba73111
352230Epivir 300 MG Oral TabletPSN13ca868d-a734-4c2f-88f0-ac1071ba73111
199147lamiVUDine 150 MG Oral TabletPSN13ca868d-a734-4c2f-88f0-ac1071ba73111
349491lamiVUDine 300 MG Oral TabletPSN13ca868d-a734-4c2f-88f0-ac1071ba73111
152931lamivudine 150 MG Oral Tablet [Epivir]SBD13ca868d-a734-4c2f-88f0-ac1071ba73111
352230lamivudine 300 MG Oral Tablet [Epivir]SBD13ca868d-a734-4c2f-88f0-ac1071ba73111
199147lamivudine 150 MG Oral TabletSCD13ca868d-a734-4c2f-88f0-ac1071ba73111
349491lamivudine 300 MG Oral TabletSCD13ca868d-a734-4c2f-88f0-ac1071ba73111
1991473TC 150 MG Oral TabletSY13ca868d-a734-4c2f-88f0-ac1071ba73111
1529313TC 150 MG Oral Tablet [Epivir]SY13ca868d-a734-4c2f-88f0-ac1071ba73111
3494913TC 300 MG Oral TabletSY13ca868d-a734-4c2f-88f0-ac1071ba73111
3522303TC 300 MG Oral Tablet [Epivir]SY13ca868d-a734-4c2f-88f0-ac1071ba73111
152931Epivir 150 MG Oral TabletSY13ca868d-a734-4c2f-88f0-ac1071ba73111
352230Epivir 300 MG Oral TabletSY13ca868d-a734-4c2f-88f0-ac1071ba73111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0246-15380802460130 in 1 BLISTER PACKHistorical