Prescription drug · NDA
Steglatro (Ertugliflozin) NDC 0006-5364
Ertugliflozin pidolate 15 mg/1 · Tablet, Film coated · Oral · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-5364-03 | 00006536403 | 30 TABLET, FILM COATED in 1 BOTTLE (0006-5364-03)Marketed from Dec 19, 2017 | |
| 0006-5364-06 | 00006536406 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-5364-06)Marketed from Dec 19, 2017 | |
| 0006-5364-07 | 00006536407 | 500 TABLET, FILM COATED in 1 BOTTLE (0006-5364-07)Marketed from Dec 19, 2017 | |
| 0006-5364-09 | 00006536409 | 2 BOTTLE in 1 CARTON (0006-5364-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5364-08)Marketed from Dec 19, 2017 |
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)
- Steglatro
- Generic name (nonproprietary)
- ertugliflozin
- Active ingredients
- Ertugliflozin pidolate — 15 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 209803
- Marketing start
- Listing expires
- Identifiers
- Product ID 0006-5364_17e6fd06-3cc6-4bad-8809-76e38dbc4471SPL ID 17e6fd06-3cc6-4bad-8809-76e38dbc4471SPL set ID e6f3e718-bb99-48f1-ab94-b9f0af05fed6RxCUI 1992810, 1992816, 1992819, 1992821UNII MLU731K321UPC 0300065363035, 0300065364032
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
N400006536403followed by a unit qualifier and the quantityPackage 00006-5364-03. 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)
STEGLATRO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. STEGLATRO is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] .
Excerpt only. Read the full label for complete information.
About NDC 0006-5364
- What is NDC 0006-5364?
- 0006-5364 is the product NDC for Steglatro (ertugliflozin), Ertugliflozin pidolate 15 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?
- Steglatro (Ertugliflozin).
- What is the active ingredient?
- Ertugliflozin pidolate.
- 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 Steglatro?
- 1 other product NDC are listed under this name. See all Steglatro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Steglatro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Steglatroertugliflozin | Ertugliflozin pidolate 5 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-5363 | 00006-5363-0300006-5363-0600006-5363-07+2 more |
Other NDCs under NDA 209803
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 |
|---|---|---|---|---|
| Steglatroertugliflozin | Ertugliflozin pidolate 5 mg/1 | Tablet, Film coatedOral | Merck Sharp & Dohme LLC | 0006-5363 |