ENTECAVIR TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 21:18:22

Label at a glance#

ProductEntecavir

Active ingredientENTECAVIR

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1019-3

Entecavir Tablets USP, 0.5 mg

Rx Only

30 tablets

NDC 70771-1020-3

Entecavir Tablets USP, 1 mg

Rx Only

30 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
485434	entecavir 0.5 MG Oral Tablet	PSN	6
485436	entecavir 1 MG Oral Tablet	PSN	6
485434	entecavir 0.5 MG Oral Tablet	SCD	6
485436	entecavir 1 MG Oral Tablet	SCD	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ENTECAVIR ANHYDROUS Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
bf657fd6-5fee-0845-3354-1dada0e72202	Product name	9	20190701

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1019-1	Entecavir	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70771-1019-2	Entecavir	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	6
70771-1019-3	Entecavir	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
70771-1019-4	Entecavir	10 in 1 CARTON	TABLET, FILM COATED	10	6
70771-1019-9	Entecavir	90 in 1 BOTTLE	TABLET, FILM COATED	90	6
70771-1020-1	Entecavir	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70771-1020-2	Entecavir	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	6
70771-1020-3	Entecavir	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
70771-1020-4	Entecavir	10 in 1 CARTON	TABLET, FILM COATED	10	6
70771-1020-9	Entecavir	90 in 1 BOTTLE	TABLET, FILM COATED	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1019	ENTECAVIR TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 5 package rows	20241201_0e3b2a0a-9076-4907-bbaf-eb6a65bb9481.zip
70771-1020	ENTECAVIR TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 5 package rows	20241201_0e3b2a0a-9076-4907-bbaf-eb6a65bb9481.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Entecavir
ENTECAVIR ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1019	70771-1019-3, 70771-1019-9, 70771-1019-1, 70771-1019-2, 70771-1019-4
70771-1020	70771-1020-3, 70771-1020-9, 70771-1020-1, 70771-1020-2, 70771-1020-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ENTECAVIR	5968Y6H45M	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSPOVIDONE	2S7830E561	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ENTECAVIR	5968Y6H45M	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSPOVIDONE	2S7830E561	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206745-001	ENTECAVIR	ENTECAVIR	0.5MG	TABLET / ORAL	AB		2017-06-23
A206745-002	ENTECAVIR	ENTECAVIR	1MG	TABLET / ORAL	AB		2017-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206745-001	AB
A206745-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206745-001	ENTECAVIR	0.5MG	TABLET / ORAL	AB	2017-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206745-002	ENTECAVIR	1MG	TABLET / ORAL	AB	2017-06-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206745-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206745-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206745-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206745-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206745-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206745-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206745-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206745-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206745-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206745-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206745-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206745-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206745-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206745-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206745-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206745-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206745-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206745-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206745-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206745-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206745-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206745-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206745-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206745-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206745-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206745-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206745-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206745-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206745-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206745-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206745-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206745-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206745-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206745-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206745-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206745-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206745-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206745-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206745-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206745-002	AB	1	`74a2ff9319b5…`

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	Zydus Lifesciences Limited	0e3b2a0a-9076-4907-bbaf-eb6a65bb9481	2024-11-28		Exact identifier ndc (package): 70771-1019-3 ndc (package): 70771-1019-9 ndc (package): 70771-1019-4 ndc (package): 70771-1019-2 ndc (package): 70771-1020-3 ndc (package): 70771-1020-1 ndc (package): 70771-1020-4 ndc (package): 70771-1020-2 ndc (package): 70771-1019-1 ndc (package): 70771-1020-9 ndc (product): 70771-1020 ndc (product): 70771-1019 ndc11 (package): 70771102001 ndc11 (package): 70771102009 ndc11 (package): 70771101902 ndc11 (package): 70771102004 ndc11 (package): 70771101904 ndc11 (package): 70771102002 ndc11 (package): 70771101909 ndc11 (package): 70771102003 ndc11 (package): 70771101903 ndc11 (package): 70771101901 spl id: eb274d01-4108-4d2e-8e2b-8656b90684c0 spl set id: 0e3b2a0a-9076-4907-bbaf-eb6a65bb9481

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.