Sitagliptin and Metformin Hydrochloride
- Product NDC
- 70710-2037
- 11-digit product format
- 707102037
- Labeler code
- 70710
- Product ID
- 70710-2037_8898638c-e4b3-4fdf-91e6-d39156e5ace9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sitagliptin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- NDA216778
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-10-31
- Substance
- METFORMIN HYDROCHLORIDE; SITAGLIPTIN
- Active strength
- 1000; 50 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sitagliptin and Metformin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
| SITAGLIPTIN | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QFP0P1DV7Z, 786Z46389E |
| Rxcui | 1243827, 1243842, 1243846 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-2037-6 | Sitagliptin and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-2037 | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 2 | Current NDC, 1 package rows | 20241101_d3a728a0-decb-4340-8ee4-c5e27c13eb19.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-2037-6 | 70710203706 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-2037-6) | 2024-10-31 | No | No | Current |