Entecavir

Product NDC: 42291-262
Requested package NDC: 42291-262-30
11-digit product format: 422910262
Labeler code: 42291
Product ID: 42291-262_d57a808f-0045-5d84-e053-2995a90a74ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Entecavir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA206652
Marketing category: ANDA
Marketing start: 2020-11-02
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: 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	42291-262	42291-262-30	D	Discontinued by firm		2026-08-03

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
A206652-001	ENTECAVIR	ENTECAVIR	0.5MG	TABLET / ORAL	AB		2015-11-12
A206652-002	ENTECAVIR	ENTECAVIR	1MG	TABLET / ORAL	AB		2015-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206652-001	AB
A206652-002	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 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	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206652-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2015-11-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206652-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2015-11-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A206652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206652-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206652-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206652-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206652-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206652-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206652-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206652-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206652-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206652-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206652-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206652-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206652-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206652-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206652-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206652-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206652-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206652-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206652-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206652-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206652-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206652-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206652-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206652-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206652-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206652-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206652-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206652-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206652-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206652-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf657fd6-5fee-0845-3354-1dada0e72202	Product name	9	20190701

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-262-30	Entecavir	30 in 1 BOTTLE	TABLET, FILM COATED	30		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-262-30	EA - Each	42291-262	a516ecab-f50d-4849-9579-e0004c580fe6	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-262	ENTECAVIR TABLET, FILM COATED [AVKARE]	11	Legacy NDC, 1 package rows	20240110_5a1cbf7e-0352-aa3b-080c-222a6423ecd8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Entecavir	ENTECAVIR	AvKARE	5a1cbf7e-0352-aa3b-080c-222a6423ecd8	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206652 application number: ANDA206652 ndc (package): 42291-262-30 ndc (product): 42291-262 ndc11 (package): 42291026230
Entecavir	ENTECAVIR	Amneal Pharmaceuticals LLC	007a6ad8-4d23-4543-ae48-c651cac7dd7b	2019-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206652 application number: ANDA206652

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485434	entecavir 0.5 MG Oral Tablet	PSN	5a1cbf7e-0352-aa3b-080c-222a6423ecd8	13
485436	entecavir 1 MG Oral Tablet	PSN	5a1cbf7e-0352-aa3b-080c-222a6423ecd8	13
485434	entecavir 0.5 MG Oral Tablet	SCD	5a1cbf7e-0352-aa3b-080c-222a6423ecd8	13
485436	entecavir 1 MG Oral Tablet	SCD	5a1cbf7e-0352-aa3b-080c-222a6423ecd8	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-262-30	42291026230	30 TABLET, FILM COATED in 1 BOTTLE (42291-262-30)	2020-11-02	0000-00-00	No	No	Current