DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Product NDC
- 70748-101
- 11-digit product format
- 707480101
- Labeler code
- 70748
- Product ID
- 70748-101_3a403a40-5f3b-4e91-8207-e55611ed8aaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA211579
- Marketing category
- ANDA
- Marketing start
- 2026-04-17
- Substance
- DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- Active strength
- 5; 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DAPAGLIFLOZIN | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 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 |
|---|---|---|---|---|---|---|
| 70748-101-06 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 15 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1593058 | dapagliflozin 10 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet | PSN | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593068 | dapagliflozin 10 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593070 | dapagliflozin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet | PSN | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593072 | dapagliflozin 5 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet | PSN | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593058 | 24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet | SCD | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593068 | 24 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593070 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet | SCD | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593072 | 24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet | SCD | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593058 | dapagliflozin (as dapagliflozin propanediol) 10 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet | SY | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593070 | dapagliflozin (as dapagliflozin propanediol) 5 MG / metformin hydrochloride 1000 MG 24 HR Extended Release Oral Tablet | SY | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593068 | dapagliflozin 10 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
| 1593072 | dapagliflozin 5 MG / metformin HCl 500 MG 24HR Extended Release Oral Tablet | SY | e6957674-86c1-4536-8e23-54ad7f2cacc4 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 70748-101-06 | 70748010106 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-101-06) | 2026-04-17 | No | No | Current |