Home NDC 51991-896 Entecavir
Product NDC 51991-896
11-digit product format 519910896
Labeler code 51991
Product ID 51991-896_b91cc0f3-f252-48f8-8623-41ad9ee59af4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Entecavir
Dosage form TABLET
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA208721
Marketing category ANDA
Marketing start 2018-03-16
Marketing end 2025-01-31
Substance ENTECAVIR
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 0000-00-00
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 · 12 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 51991-896-33 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 51991-896-33 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 51991-896-33 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 51991-896-33 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 51991-896-33 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 51991-896-33 cdf11ea48f46…ba0047e9e063…
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 A208721-001 ENTECAVIR ENTECAVIR 0.5MG TABLET / ORAL 2018-03-15 A208721-002 ENTECAVIR ENTECAVIR 1MG TABLET / ORAL 2018-03-15
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 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL 2018-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208721-002 ENTECAVIR 1MG TABLET / ORAL 2018-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL 2018-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208721-002 ENTECAVIR 1MG TABLET / ORAL 2018-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL 2018-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208721-002 ENTECAVIR 1MG TABLET / ORAL 2018-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208721-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2018-03-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208721-002 ENTECAVIR 1MG TABLET / ORAL AB 2018-03-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51991-896-33 51991089633 30 TABLET in 1 BOTTLE, PLASTIC (51991-896-33) 30 tablet 2018-03-16 0000-00-00 No No Current