Sitagliptin and Metformin Hydrochloride
- Product NDC
- 70771-1886
- 11-digit product format
- 707711886
- Labeler code
- 70771
- Product ID
- 70771-1886_586136d7-1c08-4507-a8fc-946d5cbefebb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sitagliptin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- 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 | 786Z46389E, QFP0P1DV7Z |
| Rxcui | 1243827, 1243842, 1243846 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1886-6 | Sitagliptin and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1886 | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 1 | Current NDC, 1 package rows | 20241101_a07fa1d9-7171-4f2a-ab34-f8fa410364a6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70771-1886-6 | 70771188606 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1886-6) | 2024-10-31 | No | No | Historical |