Home NDC 49702-205-48 EPIVIR
Product NDC 49702-205
Requested package NDC 49702-205-48
11-digit product format 497020205
Labeler code 49702
Product ID 49702-205_38eff3e4-ae02-40be-9f8a-5e2d99113447
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lamivudine
Dosage form SOLUTION
Route ORAL
Labeler ViiV Healthcare Company
Application NDA020596
Marketing category NDA
Marketing start 2010-10-04
Substance LAMIVUDINE
Active strength 10 mg/mL
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020596-001 EPIVIR LAMIVUDINE 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020596-001 AA
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 · 43 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 2026-09-14 22:38:34 2026-08 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020596-001 EPIVIR 10MG/ML SOLUTION / ORAL AA RLD, RS 1995-11-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base EPIVIR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LAMIVUDINE 10 mg/mL
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 49702-205-48 EPIVIR 240 mL in 1 BOTTLE SOLUTION 240 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 49702-205 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 Units Marketing start Marketing end Sample Exclude flag Status 49702-205-48 49702020548 240 mL in 1 BOTTLE (49702-205-48) 240 ml 2010-10-04 0000-00-00 No No Current