Sitagliptin and Metformin Hydrochloride
- Product NDC
- 0781-5802
- 11-digit product format
- 007815802
- Labeler code
- 0781
- Product ID
- 0781-5802_a0fcdc08-0afc-4912-a126-3efea6bc8c61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sitagliptin and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA202388
- Marketing category
- ANDA
- Marketing start
- 2025-12-02
- Substance
- METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sitagliptin and Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
| SITAGLIPTIN PHOSPHATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, TS63EW8X6F |
| Rxcui | 2709488, 2709491 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-5802-60 | Sitagliptin and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 0781-5802-71 | Sitagliptin and Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
| 0781-5802-73 | Sitagliptin and Metformin Hydrochloride | 350 in 1 BOTTLE | TABLET, FILM COATED | 350 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0781-5802-60 | 00781580260 | 60 TABLET, FILM COATED in 1 BOTTLE (0781-5802-60) | 2025-12-02 | No | No | Historical |
| 0781-5802-71 | 00781580271 | 180 TABLET, FILM COATED in 1 BOTTLE (0781-5802-71) | 2025-12-02 | No | No | Historical |
| 0781-5802-73 | 00781580273 | 350 TABLET, FILM COATED in 1 BOTTLE (0781-5802-73) | 2025-12-02 | No | No | Historical |