Saxagliptin
- Product NDC
- 0378-4706
- 11-digit product format
- 003784706
- Labeler code
- 0378
- Product ID
- 0378-4706_5844f950-ed79-43de-a6c4-2233878a9222
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- saxagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205980
- Marketing category
- ANDA
- Marketing start
- 2023-08-04
- Substance
- SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- 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
- Saxagliptin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4N19ON48ZN |
| Rxcui | 858036, 858042 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4706-77 | Saxagliptin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 4 |
| 0378-4706-93 | Saxagliptin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4706 | SAXAGLIPTIN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | Current NDC, 2 package rows | 20250322_6e8d8c4f-96eb-4b64-9c8c-4a5448a23a78.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-4706-77 | 00378470677 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4706-77) | 2023-08-04 | No | No | Historical |
| 0378-4706-93 | 00378470693 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4706-93) | 2023-08-04 | No | No | Historical |