ENTECAVIR

Product NDC: 43547-436
11-digit product format: 435470436
Labeler code: 43547
Product ID: 43547-436_a5a51ce6-2c18-40de-b266-c3891132bbd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ENTECAVIR
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Solco Healthcare LLC
Application: ANDA208782
Marketing category: ANDA
Marketing start: 2018-04-01
Substance: ENTECAVIR ANHYDROUS
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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ENTECAVIR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENTECAVIR ANHYDROUS	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NNU2O4609D	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bb1bb6dc-0120-46e2-ad1e-d9afc221fa16	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
bf657fd6-5fee-0845-3354-1dada0e72202	Product name	9	20190701
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43547-436-03	ENTECAVIR	30 in 1 BOTTLE	TABLET, FILM COATED	30	10
43547-436-09	ENTECAVIR	90 in 1 BOTTLE	TABLET, FILM COATED	90	10
43547-436-50	ENTECAVIR	500 in 1 BOTTLE	TABLET, FILM COATED	500	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-436-03	EA - Each	43547-436	993f71c7-869a-4c7b-9ed3-cd6a6f96d901	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-436	ENTECAVIR TABLET, FILM COATED [SOLCO HEALTHCARE LLC]	9	Current NDC, Legacy NDC, 3 package rows	20240801_bb1bb6dc-0120-46e2-ad1e-d9afc221fa16.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.

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 ndc (product): 43547-436

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485434	entecavir 0.5 MG Oral Tablet	PSN	bb1bb6dc-0120-46e2-ad1e-d9afc221fa16	10
485436	entecavir 1 MG Oral Tablet	PSN	bb1bb6dc-0120-46e2-ad1e-d9afc221fa16	10
485434	entecavir 0.5 MG Oral Tablet	SCD	bb1bb6dc-0120-46e2-ad1e-d9afc221fa16	10
485436	entecavir 1 MG Oral Tablet	SCD	bb1bb6dc-0120-46e2-ad1e-d9afc221fa16	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-436-03	43547043603	30 TABLET, FILM COATED in 1 BOTTLE (43547-436-03)	2018-04-01	0000-00-00	No	No	Current
43547-436-09	43547043609	90 TABLET, FILM COATED in 1 BOTTLE (43547-436-09)	2018-04-01	0000-00-00	No	No	Current
43547-436-15	43547043615	500 TABLET, FILM COATED in 1 BOTTLE (43547-436-15)	2018-04-01	0000-00-00	No	No	Current
43547-436-50	43547043650	500 TABLET, FILM COATED in 1 BOTTLE (43547-436-50)	2018-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENTECAVIR	Solco Healthcare LLC \| Prinston Pharmaceutical Inc. \| Zhejiang Huahai Pharmaceutical Co., LTD	2024-11-20	HUMAN PRESCRIPTION DRUG LABEL	10
ENTECAVIR	AvPAK	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	2