NDC 50090-3472
JANUVIA
Sitagliptin
JANUVIA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Sitagliptin Phosphate.
| Product ID | 50090-3472_8290de7f-c6c0-4d0c-95e6-4e1e4be32b29 |
| NDC | 50090-3472 |
| Product Type | Human Prescription Drug |
| Proprietary Name | JANUVIA |
| Generic Name | Sitagliptin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2006-10-16 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021995 |
| Labeler Name | A-S Medication Solutions |
| Substance Name | SITAGLIPTIN PHOSPHATE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 50090-3472-1
90 TABLET, FILM COATED in 1 BOTTLE (50090-3472-1)
| Marketing Start Date | 2018-06-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50090-3472-1 [50090347201]
JANUVIA TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021995 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-06-12 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SITAGLIPTIN PHOSPHATE | 50 mg/1 |
OpenFDA Data
| SPL SET ID: | 194c3718-5eb5-4cf5-85d0-2bb1ed8293b8 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Dipeptidyl Peptidase 4 Inhibitor [EPC]
- Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC Crossover Matching brand name "JANUVIA" or generic name "Sitagliptin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0006-0112 | JANUVIA | sitagliptin |
| 0006-0221 | JANUVIA | sitagliptin |
| 0006-0277 | JANUVIA | sitagliptin |
| 50090-3472 | JANUVIA | sitagliptin |
| 50090-3527 | JANUVIA | sitagliptin |
| 50090-4084 | JANUVIA | sitagliptin |
| 50090-4086 | JANUVIA | sitagliptin |
| 50090-4087 | JANUVIA | sitagliptin |
| 50090-5517 | JANUVIA | sitagliptin |
| 50090-5547 | JANUVIA | sitagliptin |
| 50090-5585 | JANUVIA | sitagliptin |
| 55154-5040 | JANUVIA | sitagliptin |
| 55154-5042 | JANUVIA | sitagliptin |
| 55154-5044 | JANUVIA | JANUVIA |
Trademark Results [JANUVIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 JANUVIA 78833412 3621009 Live/Registered |
MERCK SHARP & DOHME CORP. 2006-03-09 |
 JANUVIA 76635570 3261637 Live/Registered |
MERCK SHARP & DOHME CORP. 2005-04-07 |
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