NDC 0006-5363
STEGLATRO
Ertugliflozin
STEGLATRO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Llc. The primary component is Ertugliflozin Pidolate.
| Product ID | 0006-5363_10734a5e-9dac-48b0-8482-ab923b24bdfe |
| NDC | 0006-5363 |
| Product Type | Human Prescription Drug |
| Proprietary Name | STEGLATRO |
| Generic Name | Ertugliflozin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-12-19 |
| Marketing Category | NDA / NDA |
| Application Number | NDA209803 |
| Labeler Name | Merck Sharp & Dohme LLC |
| Substance Name | ERTUGLIFLOZIN PIDOLATE |
| Active Ingredient Strength | 5 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0006-5363-03
30 TABLET, FILM COATED in 1 BOTTLE (0006-5363-03)
| Marketing Start Date | 2017-12-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0006-5363-06 [00006536306]
STEGLATRO TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209803 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5363-07 [00006536307]
STEGLATRO TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209803 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5363-10 [00006536310]
STEGLATRO TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209803 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5363-03 [00006536303]
STEGLATRO TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209803 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5363-08 [00006536308]
STEGLATRO TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209803 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-19 |
NDC 0006-5363-09 [00006536309]
STEGLATRO TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA209803 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-19 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ERTUGLIFLOZIN PIDOLATE | 5 mg/1 |
OpenFDA Data
| SPL SET ID: | e6f3e718-bb99-48f1-ab94-b9f0af05fed6 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "STEGLATRO" or generic name "Ertugliflozin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0006-5363 | STEGLATRO | ertugliflozin |
| 0006-5364 | STEGLATRO | ertugliflozin |
| 50090-6182 | STEGLATRO | ertugliflozin |
| 50090-6183 | STEGLATRO | ertugliflozin |
Trademark Results [STEGLATRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STEGLATRO 86576333 5498114 Live/Registered |
Merck Sharp & Dohme Corp. 2015-03-25 |
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