STEGLUJAN
- Product NDC
- 0006-5367
- 11-digit product format
- 000065367
- Labeler code
- 0006
- Product ID
- 0006-5367_232103cc-9755-4194-867a-8679e263905a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ertugliflozin and sitagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA209805
- Marketing category
- NDA
- Marketing start
- 2017-12-19
- Substance
- ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE
- Active strength
- 5; 100 mg/1; mg/1
- Pharmacologic classes
- 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
- STEGLUJAN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ERTUGLIFLOZIN PIDOLATE | 5 mg/1 |
| SITAGLIPTIN PHOSPHATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MLU731K321, TS63EW8X6F |
| Rxcui | 1992826, 1992832, 1992835, 1992837 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-5367-03 | STEGLUJAN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
| 0006-5367-06 | STEGLUJAN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 23 |
| 0006-5367-07 | STEGLUJAN | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 23 |
| 0006-5367-08 | STEGLUJAN | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 23 |
| 0006-5367-09 | STEGLUJAN | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0006-5367 | STEGLUJAN (ERTUGLIFLOZIN AND SITAGLIPTIN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] | 23 | Current NDC, Legacy NDC, 5 package rows | 20250112_c2c553d8-5a9d-4366-bf53-8bdb5a876d19.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0006-5367-03 | 00006536703 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5367-03) | | 2017-12-19 | 0000-00-00 | No | No | Current |
| 0006-5367-06 | 00006536706 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-5367-06) | | 2017-12-19 | 0000-00-00 | No | No | Current |
| 0006-5367-07 | 00006536707 | 500 TABLET, FILM COATED in 1 BOTTLE (0006-5367-07) | | 2017-12-19 | 0000-00-00 | No | No | Current |
| 0006-5367-08 | 00006536708 | 7 in 1 BOTTLE | | | | | | Historical |
| 0006-5367-09 | 00006536709 | 2 BOTTLE in 1 CARTON (0006-5367-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5367-08) | 2 bottle | 2017-12-19 | 0000-00-00 | Yes | No | Current |