Sitagliptin and metformin hydrochloride
- Product NDC
- 70771-1870
- 11-digit product format
- 707711870
- Labeler code
- 70771
- Product ID
- 70771-1870_20a7af2d-467c-4f70-880c-49192be5d8b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sitagliptin and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- NDA216743
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-03-14
- 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 | 786Z46389E, QFP0P1DV7Z |
| Rxcui | 861769, 861819 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1870-6 | Sitagliptin and metformin hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 70771-1870-8 | Sitagliptin and metformin hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1870 | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 5 | Current NDC, 2 package rows | 20240810_e07abcb1-1f0c-4cad-8405-8eedba4b8ff8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1870-6 | 70771187006 | 60 TABLET, FILM COATED in 1 BOTTLE (70771-1870-6) | 2024-03-14 | No | No | Current |
| 70771-1870-8 | 70771187008 | 180 TABLET, FILM COATED in 1 BOTTLE (70771-1870-8) | 2024-03-14 | No | No | Current |