dapagliflozin and metformin hydrochloride
- Product NDC
- 66993-361
- 11-digit product format
- 669930361
- Labeler code
- 66993
- Product ID
- 66993-361_8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dapagliflozin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Prasco Laboratories
- Application
- NDA205649
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-01-03
- Substance
- DAPAGLIFLOZIN PROPANEDIOL; 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- dapagliflozin and metformin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAPAGLIFLOZIN PROPANEDIOL | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 887K2391VH, 786Z46389E |
| Rxcui | 1593058, 1593070 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66993-361-60 | dapagliflozin and metformin hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66993-361 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO, LLC] | 6 | Current NDC, 1 package rows | 20250123_eaf135b6-e378-4f62-a1e7-db45e23668c7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 66993-361-60 | 66993036160 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60) | 2024-01-03 | No | No | Current |