FDA.reportPublic FDA data

Dapagliflozin

Product NDC
70954-857
11-digit product format
709540857
Labeler code
70954
Product ID
70954-857_6425d240-5dd9-4a2c-9348-f8a859702850
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA211156
Marketing category
ANDA
Marketing start
2026-05-13
Substance
DAPAGLIFLOZIN
Active strength
10 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211156-001DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06
A211156-002DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211156-001AB
A211156-002AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A211156-001PC2026-10-03
A211156-002PC2026-10-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211156-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211156-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211156-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211156-002AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211156-001PC2026-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211156-002PC2026-10-03a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAPAGLIFLOZINDAPAGLIFLOZINFlorida Pharmaceutical Products, LLC20a83ea2-6ad8-4bbb-b516-73c0a9e373992026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211156
application number: ANDA211156
DapagliflozinDAPAGLIFLOZINANI Pharmaceuticals, Inc.6425d240-5dd9-4a2c-9348-f8a8597028502026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211156
application number: ANDA211156
ndc (product): 70954-857

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ULL0QJ8UCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1488569Internal RxNorm lookup
1488574Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6425d240-5dd9-4a2c-9348-f8a859702850Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c30aab5e-c89f-4b59-83b1-99a940b63351Product name120200925
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-857-10Dapagliflozin30 in 1 BOTTLETABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN6425d240-5dd9-4a2c-9348-f8a8597028501
1488574dapagliflozin 5 MG Oral TabletPSN6425d240-5dd9-4a2c-9348-f8a8597028501
1488569dapagliflozin 10 MG Oral TabletSCD6425d240-5dd9-4a2c-9348-f8a8597028501
1488574dapagliflozin 5 MG Oral TabletSCD6425d240-5dd9-4a2c-9348-f8a8597028501
1488569dapagliflozin 10 MG Oral TabletSY6425d240-5dd9-4a2c-9348-f8a8597028501
1488574dapagliflozin 5 MG Oral TabletSY6425d240-5dd9-4a2c-9348-f8a8597028501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70954-857-107095408571030 TABLET, FILM COATED in 1 BOTTLE (70954-857-10) 2026-05-13NoNoCurrent