NDC 0006-5368
STEGLUJAN
Ertugliflozin And Sitagliptin
STEGLUJAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Ertugliflozin Pidolate; Sitagliptin Phosphate.
| Product ID | 0006-5368_011d786f-9fc8-4ded-8028-2513ace66bc6 |
| NDC | 0006-5368 |
| Product Type | Human Prescription Drug |
| Proprietary Name | STEGLUJAN |
| Generic Name | Ertugliflozin And Sitagliptin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-12-19 |
| Marketing Category | NDA / NDA |
| Application Number | NDA209805 |
| Labeler Name | Merck Sharp & Dohme Corp. |
| Substance Name | ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE |
| Active Ingredient Strength | 15 mg/1; mg/1 |
| Pharm Classes | Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0006-5368-03
30 TABLET, FILM COATED in 1 BOTTLE (0006-5368-03)
| Marketing Start Date | 2017-12-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0006-5368-06 [00006536806]
STEGLUJAN TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209805 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5368-09 [00006536809]
STEGLUJAN TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209805 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5368-07 [00006536807]
STEGLUJAN TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209805 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5368-03 [00006536803]
STEGLUJAN TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209805 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5368-08 [00006536808]
STEGLUJAN TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209805 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-19 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ERTUGLIFLOZIN PIDOLATE | 15 mg/1 |
OpenFDA Data
| SPL SET ID: | c2c553d8-5a9d-4366-bf53-8bdb5a876d19 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Dipeptidyl Peptidase 4 Inhibitor [EPC]
- Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC Crossover Matching brand name "STEGLUJAN" or generic name "Ertugliflozin And Sitagliptin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0006-5367 | STEGLUJAN | ertugliflozin and sitagliptin |
| 0006-5368 | STEGLUJAN | ertugliflozin and sitagliptin |
Trademark Results [STEGLUJAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STEGLUJAN 86887773 5576254 Live/Registered |
Merck Sharp & Dohme Corp. 2016-01-27 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.