JANUVIA
- Product NDC
- 50090-1036
- 11-digit product format
- 500901036
- Labeler code
- 50090
- Product ID
- 50090-1036_57d5a9ab-a804-4a69-bdec-60a319ad8700
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sitagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA021995
- Marketing category
- NDA
- Marketing start
- 2006-10-16
- Substance
- SITAGLIPTIN PHOSPHATE
- Active strength
- 100 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
- JANUVIA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SITAGLIPTIN PHOSPHATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TS63EW8X6F |
| Rxcui | 665036, 2709603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-1036-0 | JANUVIA | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 50090-1036-2 | JANUVIA | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-1036 | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 13 | Current NDC, 2 package rows | 20240202_e2e576e6-6181-4178-b989-61d0e795e559.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-1036-0 | 50090103600 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-1036-0) | 2014-11-28 | No | No | Historical |
| 50090-1036-2 | 50090103602 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-1036-2) | 2018-06-12 | No | No | Historical |