EPIVIR

Product NDC
53808-0893
11-digit product format
538080893
Labeler code
53808
Product ID
53808-0893_50cf8e19-72f4-4202-895f-cc9f81c2ca6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamivudine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021003
Marketing category
NDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LAMIVUDINE
Active strength
100 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
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 productproduct53808-0893IInactivated by FDA2026-08-17
excluded packagepackage53808-089353808-0893-1IInactivated 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 packagepackage53808-0893-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0893-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0893-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0893-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0893-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0893-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0893-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0893-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0893-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0893-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0893-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0893-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0893-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0893-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0893-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0893-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0893-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0893-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0893-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0893-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0893-19bebd1f3094a…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
N021003-001EPIVIR-HBVLAMIVUDINE100MGTABLET / ORALRLD1998-12-08

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 06:07:402026-07N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021003-001EPIVIR-HBV100MGTABLET / ORALRLD1998-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021003-001EPIVIR-HBV100MGTABLET / ORALABRLD, RS1998-12-08e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021003-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021003-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021003-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021003-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021003-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021003-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021003-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021003-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021003-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021003-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021003-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021003-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021003-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021003-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021003-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021003-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021003-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021003-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021003-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021003-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021003-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021003-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021003-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021003-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021003-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021003-001AB1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0893-1EPIVIRHBV30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMIVUDINEACTIVE INGREDIENT2T8Q726O95EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LAMIVUDINEACTIVE MOIETY2T8Q726O95EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0893EPIVIR HBV (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141007_83009c27-f54b-47df-b8b2-e2e4e0b8f4e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213483Epivir-HBV 100 MG Oral TabletPSN83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
205328lamiVUDine 100 MG Oral TabletPSN83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
213483lamivudine 100 MG Oral Tablet [Epivir HBV]SBD83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
205328lamivudine 100 MG Oral TabletSCD83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
2053283TC 100 MG Oral TabletSY83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
2134833TC 100 MG Oral Tablet [Epivir HBV]SY83009c27-f54b-47df-b8b2-e2e4e0b8f4e81
213483Epivir HBV 100 MG Oral TabletSY83009c27-f54b-47df-b8b2-e2e4e0b8f4e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0893-15380808930130 in 1 BLISTER PACKHistorical