Steglujan NDC 0006-5367

NDC codes

FDA NDC Directory

Product NDC (as listed)0006-5367Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00006-5367Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0006-5367-03	00006536703	30 TABLET, FILM COATED in 1 BOTTLE (0006-5367-03)Marketed from Dec 19, 2017
0006-5367-06	00006536706	90 TABLET, FILM COATED in 1 BOTTLE (0006-5367-06)Marketed from Dec 19, 2017
0006-5367-07	00006536707	500 TABLET, FILM COATED in 1 BOTTLE (0006-5367-07)Marketed from Dec 19, 2017
0006-5367-09	00006536709	2 BOTTLE in 1 CARTON (0006-5367-09) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5367-08)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 — 5 mg/1Sitagliptin phosphate — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Merck Sharp & Dohme LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 209805
Marketing start: Dec 19, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0006-5367_2411ef00-2924-45da-9f6c-5dabf1afea1cSPL ID 2411ef00-2924-45da-9f6c-5dabf1afea1cSPL set ID c2c553d8-5a9d-4366-bf53-8bdb5a876d19RxCUI 1992826, 1992832, 1992835, 1992837UNII TS63EW8X6F, MLU731K321UPC 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

N400006536703 followed by a unit qualifier and the quantity

Package 00006-5367-03. 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 Jun 3, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 209805

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 209805
Product	Strength	Form · route	Labeler	Product NDC
Steglujanertugliflozin and sitagliptin	Ertugliflozin pidolate 15 mg/1; Sitagliptin phosphate 100 mg/1	Tablet, Film coatedOral	Merck Sharp & Dohme LLC	0006-5368