Dapagliflozin and Metformin hydrochloride
- Product NDC
- 59651-157
- 11-digit product format
- 596510157
- Labeler code
- 59651
- Product ID
- 59651-157_513bdf9f-774c-4f7f-935a-54d3885e80a4
- 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
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dapagliflozin and Metformin hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DAPAGLIFLOZIN | 10 mg/1 |
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 786Z46389E, 1ULL0QJ8UC |
| Rxcui | 1593058, 1593068, 1593070, 1593072 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59651-157-04 | Dapagliflozin and Metformin hydrochloride | 400 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 400 | 1 | |
| 59651-157-30 | Dapagliflozin and Metformin hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59651-157-30 | EA - Each | 59651-157 | f137c1d0-4e54-41f6-a0e0-0c4593c5d66f | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1593058 | dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet | PSN | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593068 | dapagliflozin 10 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593070 | dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet | PSN | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593072 | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593058 | 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet | SCD | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593068 | 24 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593070 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet | SCD | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593072 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593058 | dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet | SY | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593070 | dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet | SY | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593068 | dapagliflozin 10 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
| 1593072 | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | 513bdf9f-774c-4f7f-935a-54d3885e80a4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 59651-157-04 | 59651015704 | 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-157-04) | 2026-04-06 | No | No | Historical |
| 59651-157-30 | 59651015730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-157-30) | 2026-04-06 | No | No | Historical |