FDA.reportPublic FDA data

Dapagliflozin and Metformin Hydrochloride

Product NDC
42571-323
11-digit product format
425710323
Labeler code
42571
Product ID
42571-323_4f01ca78-24ac-c371-e063-6294a90a021c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapagliflozin and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA211466
Marketing category
ANDA
Marketing start
2026-10-01
Substance
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength
10; 1000 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211466-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211466-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211466-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211466-004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A211466-001AB
A211466-002AB
A211466-003AB
A211466-004AB

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 22:38:342026-08A211466-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211466-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211466-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211466-004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A211466-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211466-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211466-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211466-004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211466-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211466-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211466-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211466-004DAPAGLIFLOZIN 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 22:38:342026-08A211466-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211466-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211466-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A211466-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A211466-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211466-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211466-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211466-004AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211466-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211466-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211466-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211466-004AB1a50c72e98297…

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 HYDROCHLORIDE1000 mg/1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42571-323-0442571032304400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-323-04) 2026-10-01NoNoCurrent
42571-323-304257103233030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-323-30) 2026-10-01NoNoCurrent
42571-323-904257103239090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-323-90) 2026-10-01NoNoCurrent