Entecavir

Product NDC: 62227-101
Requested package NDC: 62227-101-03
11-digit product format: 622270101
Labeler code: 62227
Product ID: 62227-101_9f4c7e78-9c8c-5330-e053-2a95a90aa6af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Entecavir
Dosage form: TABLET
Route: ORAL
Labeler: BrightGene Bio-Medical Technology Co., Ltd.
Application: ANDA212126
Marketing category: ANDA
Marketing start: 2019-03-08
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62227-101	62227-101-03	D	Discontinued by firm		2026-08-03

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, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A212126-001	ENTECAVIR	ENTECAVIR	0.5MG	TABLET / ORAL	AB		2019-09-25
A212126-002	ENTECAVIR	ENTECAVIR	1MG	TABLET / ORAL	AB		2019-09-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212126-001	AB
A212126-002	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212126-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2019-09-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212126-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2019-09-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212126-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212126-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212126-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212126-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212126-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212126-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212126-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212126-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212126-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212126-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212126-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212126-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212126-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212126-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212126-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212126-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212126-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212126-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212126-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212126-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212126-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212126-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212126-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212126-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212126-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212126-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212126-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212126-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212126-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212126-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212126-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212126-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212126-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212126-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212126-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212126-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212126-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212126-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212126-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212126-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
62227-101-01	2023-02-09	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
62227-101-02	2023-02-09	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
62227-101-03	2023-02-09	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
62227-101-01	2023-01-30	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
62227-101-02	2023-01-30	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
62227-101-03	2023-01-30	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

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	EPIC PHARMA, LLC	af4f47e2-f556-40f2-a0fd-ff81e9f27429	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212126 application number: ANDA212126

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5968Y6H45M	ENTECAVIR	209216-23-9	ENTECAVIR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62227-101-03	62227010103	3000 TABLET in 1 BOTTLE, PLASTIC (62227-101-03)	3000 tablet	2019-03-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Entecavir	BrightGene Bio-Medical Technology Co., Ltd. \| Visum Pharmaceutical Co., Ltd.	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	7