Dapagliflozin and Metformin Hydrochloride
- Product NDC
- 33342-406
- 11-digit product format
- 333420406
- Labeler code
- 33342
- Product ID
- 33342-406_7d575ca8-9c1f-469d-a341-34daf2f036dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dapagliflozin and Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA211559
- Marketing category
- ANDA
- Marketing start
- 2026-04-06
- 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 table| Ingredient | Strength |
|---|
| DAPAGLIFLOZIN | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 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 |
|---|
| 33342-406-06 | Dapagliflozin and Metformin Hydrochloride | 3 in 1 CARTON | TABLET, EXTENDED RELEASE | 3 | | 1 |
| 33342-406-07 | Dapagliflozin and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 33342-406-09 | Dapagliflozin and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 1 |
| 33342-406-10 | Dapagliflozin and Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 1 |
| 33342-406-15 | Dapagliflozin and Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 1 |
| 33342-406-66 | Dapagliflozin and Metformin Hydrochloride | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-406-06 | 33342040606 | 3 BLISTER PACK in 1 CARTON (33342-406-06) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (33342-406-66) | 3 blister pack | 2026-04-06 | No | No | Current |
| 33342-406-07 | 33342040607 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-07) | | 2026-04-06 | No | No | Current |
| 33342-406-09 | 33342040609 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-09) | | 2026-04-06 | No | No | Current |
| 33342-406-10 | 33342040610 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-10) | | 2026-04-06 | No | No | Current |
| 33342-406-15 | 33342040615 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-406-15) | | 2026-04-06 | No | No | Current |
| 33342-406-66 | 33342040666 | 10 in 1 BLISTER PACK | | | | | Historical |