Saxagliptin
- Product NDC
- 65862-825
- 11-digit product format
- 658620825
- Labeler code
- 65862
- Product ID
- 65862-825_ac9f5784-0c62-42f2-bc34-4cef2486b7f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Saxagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA205972
- Marketing category
- ANDA
- Marketing start
- 2023-07-31
- Substance
- SAXAGLIPTIN HYDROCHLORIDE
- Active strength
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z8J84YIX6L |
| Rxcui | 858036, 858042 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-825-01 | Saxagliptin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 65862-825-05 | Saxagliptin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 65862-825-30 | Saxagliptin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 65862-825-90 | Saxagliptin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-825 | SAXAGLIPTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 3 | Current NDC, 4 package rows | 20241212_f3ea58bb-0002-4a5d-9213-7e9066e3dc9c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65862-825-01 | 65862082501 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-825-01) | 2023-07-31 | No | No | Historical |
| 65862-825-05 | 65862082505 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-825-05) | 2023-07-31 | No | No | Historical |
| 65862-825-30 | 65862082530 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-825-30) | 2023-07-31 | No | No | Historical |
| 65862-825-90 | 65862082590 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-825-90) | 2023-07-31 | No | No | Historical |