JANUMET
- Product NDC
- 50090-4411
- 11-digit product format
- 500904411
- Labeler code
- 50090
- Product ID
- 50090-4411_4af91363-ea59-4586-9fff-5520215b1b25
- 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
- Marketing end
- 0000-00-00
- Substance
- SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
- Active strength
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4411-0 | JANUMET XR | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 4 |
| 50090-4411-1 | JANUMET XR | 180 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 180 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4411 | JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 4 | Legacy NDC, 2 package rows | 20210207_6d1c5225-a457-438c-93fa-15697db02363.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-4411-0 | 50090441100 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4411-0) | 2019-07-16 | 0000-00-00 | No | No | Current |
| 50090-4411-1 | 50090441101 | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4411-1) | 2019-08-09 | 0000-00-00 | No | No | Current |