ENTECAVIR

Product NDC: 50268-289
Requested package NDC: 50268-289-12
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

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	50268-289	50268-289-12	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
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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208782-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208782-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208782-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208782-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208782-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208782-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208782-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208782-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208782-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208782-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208782-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208782-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208782-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208782-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208782-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208782-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208782-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208782-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208782-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208782-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208782-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208782-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208782-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208782-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208782-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208782-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208782-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208782-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208782-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208782-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208782-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208782-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208782-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A208782-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208782-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A208782-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208782-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208782-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208782-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208782-002	AB	1	`1c564ffb4f44…`

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NNU2O4609D	ENTECAVIR ANHYDROUS	142217-69-4	ENTECAVIR ANHYDROUS
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
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