JANUMET
- Product NDC
- 50090-5504
- 11-digit product format
- 500905504
- Labeler code
- 50090
- Product ID
- 50090-5504_daeedefc-b17c-4c81-8677-dc75b1eb8af2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sitagliptin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA202270
- Marketing category
- NDA
- Marketing start
- 2012-02-02
- Substance
- METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
- Active strength
- 1000; 50 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
- JANUMET
- Brand name suffix
- XR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
| SITAGLIPTIN PHOSPHATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, TS63EW8X6F |
| Rxcui | 1243843, 2709477 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5504-0 | JANUMET XR | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 7 |
| 50090-5504-1 | JANUMET XR | 180 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 180 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5504 | JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 7 | Current NDC, 2 package rows | 20230623_90c0244b-afb3-4e69-b79f-486d002ca432.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-5504-0 | 50090550400 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-0) | 2021-03-31 | No | No | Current |
| 50090-5504-1 | 50090550401 | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5504-1) | 2021-09-01 | No | No | Current |