Linagliptin and metformin hydrochloride
- Product NDC
- 72205-408
- 11-digit product format
- 722050408
- Labeler code
- 72205
- Product ID
- 72205-408_5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linagliptin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA208459
- Marketing category
- ANDA
- Marketing start
- 2025-11-03
- Substance
- LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- Active strength
- 2.5; 850 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
- Linagliptin and metformin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LINAGLIPTIN | 2.5 mg/1 |
| METFORMIN HYDROCHLORIDE | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, 3X29ZEJ4R2 |
| Rxcui | 1243020, 1243027, 1243034 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-408-01 | Linagliptin and metformin hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 72205-408-02 | Linagliptin and metformin hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-408-01 | 72205040801 | 60 TABLET, FILM COATED in 1 BOTTLE (72205-408-01) | 2025-11-04 | No | No | Current |
| 72205-408-02 | 72205040802 | 180 TABLET, FILM COATED in 1 BOTTLE (72205-408-02) | 2025-11-04 | No | No | Current |