Dapagliflozin Tablets

Manufacturer: Zydus Lifesciences Limited
Effective date: 2026-04-06
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 22:14:11

Label at a glance#

ProductDapagliflozin

Active ingredientDAPAGLIFLOZIN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dapagliflozin Tablets, 5 mg

NDC 70771-1714-3

Bottles of 30 tablets

Rx only

Dapagliflozin Tablets, 10 mg

NDC 70771-1715-3

Bottles of 30 tablets

Rx only

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1488569	Dapagliflozin (Oral Pill)	dapagliflozin 10 MG Oral Tablet	SCD Active
1488574	Dapagliflozin (Oral Pill)	dapagliflozin 5 MG Oral Tablet	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1488569	dapagliflozin 10 MG Oral Tablet	PSN	6
1488574	dapagliflozin 5 MG Oral Tablet	PSN	6
1488569	dapagliflozin 10 MG Oral Tablet	SCD	6
1488574	dapagliflozin 5 MG Oral Tablet	SCD	6
1488569	dapagliflozin 10 MG Oral Tablet	SY	6
1488574	dapagliflozin 5 MG Oral Tablet	SY	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DAPAGLIFLOZIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c30aab5e-c89f-4b59-83b1-99a940b63351	Product name	1	20200925
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
85b4e38c-4488-4e48-919e-244e107d9bd9	Product name	2	20190731
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1714-3	Dapagliflozin	30 in 1 BOTTLE	TABLET	30	6
70771-1714-9	Dapagliflozin	90 in 1 BOTTLE	TABLET	90	6
70771-1715-3	Dapagliflozin	30 in 1 BOTTLE	TABLET	30	6
70771-1715-9	Dapagliflozin	90 in 1 BOTTLE	TABLET	90	6

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Dapagliflozin
ANHYDROUS LACTOSE
CROSPOVIDONE
HYPROMELLOSE 2910 (3 MPA.S)
MICROCRYSTALLINE CELLULOSE
POLOXAMER 407
POLYETHYLENE GLYCOL 6000
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1714	70771-1714-3, 70771-1714-9
70771-1715	70771-1715-3, 70771-1715-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DAPAGLIFLOZIN	1ULL0QJ8UC	ACTIB
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CROSPOVIDONE	2S7830E561	IACT
HYPROMELLOSE 2910 (3 MPA.S)	0VUT3PMY82	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DAPAGLIFLOZIN	1ULL0QJ8UC	ACTIB
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CROSPOVIDONE	2S7830E561	IACT
HYPROMELLOSE 2910 (3 MPA.S)	0VUT3PMY82	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

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
A211582-001	DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB		2026-04-06
A211582-002	DAPAGLIFLOZIN	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB		2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211582-001	AB
A211582-002	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.

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	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2026-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2026-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2026-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2026-04-06	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2022-02-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2022-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2022-02-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2022-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2022-02-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2022-02-22	`4b0b4de00fa7…`
2024-02-18 07:12 UTC	2024-02	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL		2022-02-22	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL		2022-02-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2022-02-22	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2022-02-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211582-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2026-04-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211582-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2026-04-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211582-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211582-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211582-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211582-002	AB	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211582-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211582-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211582-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211582-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211582-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211582-002	AB	1	`4b0b4de00fa7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211582-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211582-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211582-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211582-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dapagliflozin	DAPAGLIFLOZIN	Zydus Lifesciences Limited	db668c5c-2d49-41c8-8ffd-c2b2652b621a	2026-04-06		Exact identifier ndc (package): 70771-1715-3 ndc (package): 70771-1715-9 ndc (package): 70771-1714-3 ndc (package): 70771-1714-9 ndc (product): 70771-1715 ndc (product): 70771-1714 ndc11 (package): 70771171509 ndc11 (package): 70771171409 ndc11 (package): 70771171403 ndc11 (package): 70771171503 spl id: e0ce1921-cd6e-4663-acd0-ae34bd8222fa spl set id: db668c5c-2d49-41c8-8ffd-c2b2652b621a

Reported adverse events (FAERS/openFDA)#

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