Home NDC 50268-289 ENTECAVIR
Product NDC 50268-289
11-digit product format 502680289
Labeler code 50268
Product ID 50268-289_d5cef9cd-9b5f-8bbc-e053-2995a90a2c7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENTECAVIR
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvPAK
Application ANDA208782
Marketing category ANDA
Marketing start 2020-10-06
Marketing end 0000-00-00
Substance ENTECAVIR ANHYDROUS
Active strength 1 mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50268-289-12 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50268-289-12 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50268-289-12 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50268-289-12 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50268-289-12 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50268-289-12 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50268-289-12 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50268-289-12 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50268-289-12 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50268-289-12 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50268-289-12 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50268-289-12 557ba5c1ecfa…9c80585c8c6e…
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 A208782-001 ENTECAVIR ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 A208782-002 ENTECAVIR ENTECAVIR 1MG TABLET / ORAL 2017-10-10
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 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ENTECAVIR ENTECAVIR Solco Healthcare LLC bb1bb6dc-0120-46e2-ad1e-d9afc221fa16 2024-11-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208782 application number: ANDA208782
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-289-12 50268028912 20 BLISTER PACK in 1 BOX (50268-289-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-289-11) 20 blister pack 2020-10-06 0000-00-00 No No Current