Entecavir

Product NDC: 63126-101
11-digit product format: 631260101
Labeler code: 63126
Product ID: 63126-101_296df15a-92f7-4bec-916b-441fc1c71b3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Entecavir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: YUNG SHIN PHARM. IND. CO., LTD.
Application: ANDA208195
Marketing category: ANDA
Marketing start: 2022-04-30
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: 2022-12-31
Current FDA listing: Historical FDA.report record

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
A208195-001	ENTECAVIR	ENTECAVIR	0.5MG	TABLET / ORAL	AB		2021-11-10
A208195-002	ENTECAVIR	ENTECAVIR	1MG	TABLET / ORAL	AB		2021-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208195-001	AB
A208195-002	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 · 66 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	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL		2021-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208195-002	ENTECAVIR	1MG	TABLET / ORAL		2021-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL		2021-11-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208195-002	ENTECAVIR	1MG	TABLET / ORAL		2021-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL		2021-11-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208195-002	ENTECAVIR	1MG	TABLET / ORAL		2021-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2021-11-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208195-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2021-11-10	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208195-001	ENTECAVIR	0.5MG	TABLET / ORAL		2021-11-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208195-002	ENTECAVIR	1MG	TABLET / ORAL		2021-11-10	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208195-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208195-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208195-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208195-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208195-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208195-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208195-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208195-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208195-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208195-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208195-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208195-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208195-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208195-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208195-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208195-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208195-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208195-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208195-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208195-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208195-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208195-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208195-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208195-002	AB	1	`301d65b070ca…`
2022-04-08 23:34 UTC	2022-04	A208195-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208195-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208195-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208195-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208195-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208195-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208195-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208195-002	AB	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208195-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208195-002	AB	1	`a50c72e98297…`

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	Golden State Medical Supply, Inc.	20d62f1a-2e48-69dd-e063-6294a90ace31	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208195 application number: ANDA208195
Entecavir	ENTECAVIR	Carlsbad Technology, Inc.	1a905283-0057-a7dd-e063-6394a90a1909	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208195 application number: ANDA208195

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	Marketing start	Marketing end	Sample	Exclude flag	Status
63126-101-30	63126010130	30 TABLET, FILM COATED in 1 BOTTLE (63126-101-30)	2022-04-30	0000-00-00	No	No	Current
63126-101-90	63126010190	90 TABLET, FILM COATED in 1 BOTTLE (63126-101-90)	2022-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Entecavir	YUNG SHIN PHARM. IND. CO., LTD. \| Yung Shin Pharmaceutical Industrual Co., Ltd.	2021-11-16	HUMAN PRESCRIPTION DRUG LABEL	3