Dapagliflozin

Product NDC: 72205-432
Requested package NDC: 72205-432-03
11-digit product format: 722050432
Labeler code: 72205
Product ID: 72205-432_5d0fd8b1-1a08-4c86-86f3-06f7ebf6b211
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dapagliflozin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novadoz Pharmaceuticals LLC
Application: ANDA211478
Marketing category: ANDA
Marketing start: 2026-04-06
Substance: DAPAGLIFLOZIN
Active strength: 5 mg/1
Pharmacologic classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211478-001	DAPAGLIFLOZIN	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB		2026-04-06
A211478-002	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
A211478-001	AB
A211478-002	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
2026-08-18 06:07:40	2026-07	A211478-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2026-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211478-002	DAPAGLIFLOZIN	10MG	TABLET / ORAL	AB	2026-04-06	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211478-001	DAPAGLIFLOZIN	5MG	TABLET / ORAL	AB	2026-04-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211478-002	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
2026-08-18 06:07:40	2026-07	A211478-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211478-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211478-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211478-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dapagliflozin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPAGLIFLOZIN	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1ULL0QJ8UC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1488569	Internal RxNorm lookup
1488574	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
107b4d25-4764-42b7-80e3-9aaff20865ed	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
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
72205-432-01	Dapagliflozin	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
72205-432-02	Dapagliflozin	500 in 1 BOTTLE	TABLET, FILM COATED	500	2
72205-432-03	Dapagliflozin	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72205-432-01	EA - Each	72205-432	765d4041-e3d5-470c-b6fa-91a59719fb26	1	2026-05-22
72205-432-03	EA - Each	72205-432	31e56c82-5dcd-4c12-b0d2-a64b6e1a4d3c	1	2026-05-22

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
Dapagliflozin	DAPAGLIFLOZIN	Novadoz Pharmaceuticals LLC	107b4d25-4764-42b7-80e3-9aaff20865ed	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211478 application number: ANDA211478 ndc (package): 72205-432-03 ndc (product): 72205-432 ndc11 (package): 72205043203
Dapagliflozin	DAPAGLIFLOZIN	AvKARE	52a778e7-6044-2049-e063-6294a90aa0b7	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211478 application number: ANDA211478

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1ULL0QJ8UC	DAPAGLIFLOZIN	461432-26-8	DAPAGLIFLOZIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1488569	dapagliflozin 10 MG Oral Tablet	PSN	107b4d25-4764-42b7-80e3-9aaff20865ed	2
1488574	dapagliflozin 5 MG Oral Tablet	PSN	107b4d25-4764-42b7-80e3-9aaff20865ed	2
1488569	dapagliflozin 10 MG Oral Tablet	SCD	107b4d25-4764-42b7-80e3-9aaff20865ed	2
1488574	dapagliflozin 5 MG Oral Tablet	SCD	107b4d25-4764-42b7-80e3-9aaff20865ed	2
1488569	dapagliflozin 10 MG Oral Tablet	SY	107b4d25-4764-42b7-80e3-9aaff20865ed	2
1488574	dapagliflozin 5 MG Oral Tablet	SY	107b4d25-4764-42b7-80e3-9aaff20865ed	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72205-432-03	72205043203	90 TABLET, FILM COATED in 1 BOTTLE (72205-432-03)	2026-04-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dapagliflozin	Novadoz Pharmaceuticals LLC \| MSN LABORATORIES PRIVATE LIMITED \| MSN Pharmaceuticals Inc.	2026-06-17	Human Prescription Drug Label	3