Saxagliptin and Metformin
- Product NDC
- 0378-8177
- 11-digit product format
- 003788177
- Labeler code
- 0378
- Product ID
- 0378-8177_09385285-c5a1-444e-9c2e-64da50e2a508
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- saxagliptin and metformin
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205981
- Marketing category
- ANDA
- Marketing start
- 2023-08-08
- Substance
- METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
- Active strength
- 1000; 5 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 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
- Saxagliptin and Metformin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
| SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, 4N19ON48ZN |
| Rxcui | 1043563, 1043570, 1043578 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-8177-93 | Saxagliptin and Metformin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8177 | SAXAGLIPTIN AND METFORMIN TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, 1 package rows | 20250331_cbf8677c-cafe-48bc-8844-0cc6547886bd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-8177-93 | 00378817793 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8177-93) | 2023-08-08 | No | No | Historical |