FDA.reportPublic FDA data

Dapagliflozin and Metformin Hydrochloride

Product NDC
63304-027
11-digit product format
633040027
Labeler code
63304
Product ID
63304-027_5bac1e03-5062-a6b3-e063-6394a90aacf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA211491
Marketing category
ANDA
Marketing start
2026-04-06
Substance
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength
10; 500 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], 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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211491-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211491-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211491-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211491-001AB
A211491-002AB
A211491-003AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A211491-001PC2026-10-03
A211491-002PC2026-10-03
A211491-003PC2026-10-03

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
2026-09-14 22:38:342026-08A211491-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211491-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211491-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A211491-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211491-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211491-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211491-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211491-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211491-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A211491-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211491-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211491-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-003AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08A211491-001PC2026-10-0384e616aacf4f…
2026-09-14 22:38:342026-08A211491-002PC2026-10-0384e616aacf4f…
2026-09-14 22:38:342026-08A211491-003PC2026-10-0384e616aacf4f…
2026-08-18 06:07:402026-07A211491-001PC2026-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A211491-002PC2026-10-03caaa826d4ba7…
2026-08-18 06:07:402026-07A211491-003PC2026-10-03caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-001PC2026-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-002PC2026-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-003PC2026-10-03a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN10 mg/1
METFORMIN HYDROCHLORIDE500 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
c30aab5e-c89f-4b59-83b1-99a940b63351Product name120200925
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-027-30Dapagliflozin and Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
63304-027-54Dapagliflozin and Metformin Hydrochloride400 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE4002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-027-30EA - Each63304-027d0a3a9cb-23c8-47e4-b7c2-1e2523956d1a12026-05-22

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.54027b70-53e7-3710-e063-6394a90aa04c2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211491
application number: ANDA211491

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593058dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSNbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2
1593068dapagliflozin 10 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2
1593070dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSNbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2
159305824 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCDbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2
159306824 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCDbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2
159307024 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCDbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2
1593058dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral TabletSYbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2
1593070dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral TabletSYbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2
1593068dapagliflozin 10 MG / metformin HCl 500 MG 24HR Extended Release Oral TabletSYbddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63304-027-306330400273030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-027-30) 2026-04-06NoNoCurrent
63304-027-5463304002754400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-027-54) 2026-04-06NoNoCurrent