DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Product NDC
- 72205-437
- 11-digit product format
- 722050437
- Labeler code
- 72205
- Product ID
- 72205-437_4f890458-be94-4baf-b606-83a097e1e23e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA211479
- 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 table| Ingredient | Strength |
|---|
| DAPAGLIFLOZIN | 10 mg/1 |
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, 1ULL0QJ8UC |
| Rxcui | 1593058, 1593068, 1593070, 1593072 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-437-01 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 72205-437-02 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | 400 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 400 | | 1 |
| 72205-437-03 | 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 |
|---|
| 72205-437-01 | 72205043701 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-437-01) | 2026-04-09 | No | No | Current |
| 72205-437-02 | 72205043702 | 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-437-02) | 2026-04-09 | No | No | Current |
| 72205-437-03 | 72205043703 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-437-03) | 2026-04-09 | No | No | Current |