Home NDC 50771-013 ENTECAVIR
Product NDC 50771-013
11-digit product format 507710013
Labeler code 50771
Product ID 50771-013_4502e388-5064-bd87-e063-6294a90a4b1c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name entecavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Yaopharma Co., Ltd.
Application ANDA212201
Marketing category ANDA
Marketing start 2023-07-01
Substance ENTECAVIR
Active strength .5 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 2026-12-31
Current FDA listing Yes 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 · 9 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 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50771-013-01 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50771-013-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50771-013-01 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50771-013-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50771-013-01 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50771-013-02 1332a3947898…d4bfe170f9cd…
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 A212201-001 ENTECAVIR ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 A212201-002 ENTECAVIR ENTECAVIR 1MG TABLET / ORAL 2019-11-04
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 · 78 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 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2019-11-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A212201-002 ENTECAVIR 1MG TABLET / ORAL AB 2019-11-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212201-001 ENTECAVIR 0.5MG TABLET / ORAL 2019-11-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212201-002 ENTECAVIR 1MG TABLET / ORAL 2019-11-04 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ENTECAVIR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTECAVIR .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5968Y6H45M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485434 Internal RxNorm lookup 485436 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# NDC, Effective, Related label table NDC Effective Related label 50771-013-01 2024-06-24 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 2005 50771-013-01 2024-06-24 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 2005 50771-013-02 2024-06-24 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 2005 50771-013-02 2024-06-24 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 2005 50771-013-01 2024-01-30 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 2005 50771-013-01 2024-01-30 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 2005 50771-013-02 2024-01-30 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 2005 50771-013-02 2024-01-30 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR TABLETS, for oral use Initial U.S. Approval: 2005
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50771-013-01 ENTECAVIR 30 in 1 BOTTLE TABLET, FILM COATED 30 12 50771-013-02 ENTECAVIR 90 in 1 BOTTLE TABLET, FILM COATED 90 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50771-013 ENTECAVIR TABLET, FILM COATED [YAOPHARMA CO., LTD.] 10 Current NDC, Legacy NDC, 2 package rows 20241220_73dea2a4-a596-477f-b66d-5a80dd019837.zip
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.
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 50771-013-01 50771001301 30 TABLET, FILM COATED in 1 BOTTLE (50771-013-01) 2023-07-01 0000-00-00 No No Current 50771-013-02 50771001302 90 TABLET, FILM COATED in 1 BOTTLE (50771-013-02) 2023-07-01 0000-00-00 No No Current