Home NDC 49702-204-13 EPIVIR
Product NDC 49702-204
Requested package NDC 49702-204-13
11-digit product format 497020204
Labeler code 49702
Product ID 49702-204_3d326658-e562-4d27-a0ad-ca2017db2e49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamivudine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ViiV Healthcare Company
Application NDA020564
Marketing category NDA
Marketing start 2010-10-04
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 Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020564-001 EPIVIR LAMIVUDINE 150MG TABLET / ORAL AB RLD 1995-11-17 N020564-003 EPIVIR LAMIVUDINE 300MG TABLET / ORAL AB RLD, RS 2002-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020564-001 EPIVIR 150MG TABLET / ORAL AB RLD 1995-11-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020564-003 EPIVIR 300MG TABLET / ORAL AB RLD, RS 2002-06-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base EPIVIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMIVUDINE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2T8Q726O95 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 152931 Internal RxNorm lookup 152932 Internal RxNorm lookup 199147 Internal RxNorm lookup 199148 Internal RxNorm lookup 349491 Internal RxNorm lookup 352230 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49702-204-13 EPIVIR 30 in 1 BOTTLE TABLET, FILM COATED 30 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LAMIVUDINE ACTIVE INGREDIENT 2T8Q726O95 EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 LAMIVUDINE ACTIVE MOIETY 2T8Q726O95 EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 SUCROSE INACTIVE INGREDIENT C151H8M554 EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-204 EPIVIR (LAMIVUDINE) TABLET, FILM COATED EPIVIR (LAMIVUDINE) SOLUTION [VIIV HEALTHCARE COMPANY] 22 Current NDC, Legacy NDC, 1 package rows 20241017_89226149-47fa-4f7d-bb1f-1aa7034486b8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49702-204-13 49702020413 30 TABLET, FILM COATED in 1 BOTTLE (49702-204-13) 2010-10-04 0000-00-00 No No Current