alogliptin and metformin hydrochloride
- Product NDC
- 45802-169
- 11-digit product format
- 458020169
- Labeler code
- 45802
- Product ID
- 45802-169_187b18ba-520f-45dd-9d6f-57a833962da1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alogliptin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- NDA203414
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-04-08
- Substance
- ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
- Active strength
- 12.5; 500 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
- alogliptin and metformin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALOGLIPTIN BENZOATE | 12.5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, EEN99869SC |
| Rxcui | 1368385, 1368392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-169-72 | alogliptin and metformin hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-169 | ALOGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 18 | Current NDC, Legacy NDC, 1 package rows | 20250501_14d98490-4f8f-4d2f-a4e9-7a3d7a0199ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45802-169-72 | 45802016972 | 60 TABLET, FILM COATED in 1 BOTTLE (45802-169-72) | 2016-04-08 | 0000-00-00 | No | No | Current |