Home NDC 59651-155-30 Dapagliflozin and Metformin hydrochloride
Product NDC 59651-155
Requested package NDC 59651-155-30
11-digit product format 596510155
Labeler code 59651
Product ID 59651-155_8800b2c7-e3be-4205-913f-466e0ea9cb66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dapagliflozin and Metformin hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA211489
Marketing category ANDA
Marketing start 2026-04-06
Substance DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength 5; 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 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211489-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211489-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211489-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 A211489-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A211489-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211489-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211489-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211489-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211489-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211489-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211489-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211489-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211489-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211489-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211489-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211489-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211489-001 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211489-002 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211489-003 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;500MG TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211489-004 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG;1GM TABLET, EXTENDED RELEASE / ORAL AB 2026-04-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 Ingredient Strength DAPAGLIFLOZIN 5 mg/1 METFORMIN HYDROCHLORIDE 1000 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-155-04 Dapagliflozin and Metformin hydrochloride 400 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 400 1 59651-155-30 Dapagliflozin and Metformin hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 1 59651-155-60 Dapagliflozin and Metformin hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 60 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-155-30 59651015530 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-155-30) 2026-04-06 No No Current