Saxagliptin and Metformin Hydrochloride
- Product NDC
- 43598-620
- 11-digit product format
- 435980620
- Labeler code
- 43598
- Product ID
- 43598-620_4e06c7a2-2e47-46dd-6637-03dddb2ef8c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Saxagliptin and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA207678
- Marketing category
- ANDA
- Marketing start
- 2023-08-09
- Substance
- METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
- Active strength
- 500; 5 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
- Saxagliptin and Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
| SAXAGLIPTIN | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, 9GB927LAJW |
| Rxcui | 1043563, 1043570, 1043578 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-620-30 | Saxagliptin and Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-620 | SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DR.REDDYS LABORATORIES INC] | 6 | Current NDC, 1 package rows | 20250122_65884427-4dde-63bb-a23f-36a7779c0a6b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-620-30 | 43598062030 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-620-30) | 2023-08-09 | No | No | Current |