FDA.reportPublic FDA data

Dapagliflozin

Product NDC
70748-105
11-digit product format
707480105
Labeler code
70748
Product ID
70748-105_8aa1a0ad-3c2c-4534-ad85-b536748300bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA211531
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 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
A211531-001DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06
A211531-002DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET / 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
A211531-001AB
A211531-002AB

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
2026-08-01 22:54:322026-06A211531-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-08-01 22:54:322026-06A211531-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211531-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211531-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DapagliflozinDAPAGLIFLOZINLupin Pharmaceuticals, Inc.08baca21-e39e-4e61-961f-d89432fe80072026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211531
application number: ANDA211531
ndc (product): 70748-105

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN5 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
08baca21-e39e-4e61-961f-d89432fe8007Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70748-105-012020-01-31C16284748780-19d75b9d1-0288-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014
70748-105-022020-01-31C16284748780-19d75b9d1-0288-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014
70748-105-062020-01-31C16284748780-19d75b9d1-0288-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014
70748-105-092020-01-31C16284748780-19d75b9d1-0288-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70748-105-06Dapagliflozin30 in 1 BOTTLETABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-105-06EA - Each70748-105a601be9c-bfa1-457c-9e18-c8c972778fd412026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN08baca21-e39e-4e61-961f-d89432fe800714
1488574dapagliflozin 5 MG Oral TabletPSN08baca21-e39e-4e61-961f-d89432fe800714
1488569dapagliflozin 10 MG Oral TabletSCD08baca21-e39e-4e61-961f-d89432fe800714
1488574dapagliflozin 5 MG Oral TabletSCD08baca21-e39e-4e61-961f-d89432fe800714
1488569dapagliflozin 10 MG Oral TabletSY08baca21-e39e-4e61-961f-d89432fe800714
1488574dapagliflozin 5 MG Oral TabletSY08baca21-e39e-4e61-961f-d89432fe800714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-105-067074801050630 TABLET in 1 BOTTLE (70748-105-06) 30 tablet2026-04-06NoNoCurrent