Prescription drug · NDA
Steglujan (Ertugliflozin and sitagliptin) NDC 0006-5368
Ertugliflozin pidolate 15 mg/1; Sitagliptin phosphate 100 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-5368-03 | 0000653680300006536803 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5368-03)Marketed from Dec 19, 2017 | |
| 0006-5368-06 | 0000653680600006536806 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-5368-06)Marketed from Dec 19, 2017 | |
| 0006-5368-07 | 0000653680700006536807 | 500 TABLET, FILM COATED in 1 BOTTLE (0006-5368-07)Marketed from Dec 19, 2017 | |
| 0006-5368-09 | 0000653680900006536809 | 2 BOTTLE in 1 CARTON (0006-5368-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5368-08)Marketed from Dec 19, 2017 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Steglujan
- Generic name (nonproprietary)
- ertugliflozin and sitagliptin
- Active ingredients
- Ertugliflozin pidolate — 15 mg/1Sitagliptin phosphate — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209805
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-5368_2411ef00-2924-45da-9f6c-5dabf1afea1cSPL ID 2411ef00-2924-45da-9f6c-5dabf1afea1cSPL set ID c2c553d8-5a9d-4366-bf53-8bdb5a876d19RxCUI 1992826, 1992832, 1992835, 1992837UNII MLU731K321, TS63EW8X6FUPC 0300065368030, 0300065367033
- Pharmacologic class
- Dipeptidyl Peptidase 4 Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400006536803followed by a unit qualifier and the quantityPackage 00006-5368-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
STEGLUJAN ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ]. Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.2) ] . STEGLUJAN is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is indicated …
Excerpt only. Read the full label for complete information.
About NDC 0006-5368
- What is NDC 0006-5368?
- 0006-5368 is the product NDC for Steglujan, Ertugliflozin pidolate 15 mg/1; Sitagliptin phosphate 100 mg/1 tablet, film coated, listed with the FDA by Merck Sharp & Dohme LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Steglujan (Ertugliflozin and sitagliptin).
- What is the active ingredient?
- Ertugliflozin pidolate, Sitagliptin phosphate.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Steglujan?
- 1 other product NDC are listed under this name. See all Steglujan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Steglujan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Steglujanertugliflozin and sitagliptin | Ertugliflozin pidolate 5 mg/1; Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-5367 | 00006-5367-0300006-5367-0600006-5367-07+1 more |
Other NDCs under NDA 209805
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Steglujanertugliflozin and sitagliptin | Ertugliflozin pidolate 5 mg/1; Sitagliptin phosphate 100 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-5367 |