What is NDC 0781-5768?

0781-5768 is the product NDC for Sitagliptin Phosphate, Sitagliptin phosphate 50 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sitagliptin Phosphate?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sitagliptin Phosphate NDC 0781-5768

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5768Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5768Add 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	Copy
0781-5768-31	0078157683100781576831	30 TABLET, FILM COATED in 1 BOTTLE (0781-5768-31)Marketed from Jan 14, 2026
0781-5768-92	0078157689200781576892	90 TABLET, FILM COATED in 1 BOTTLE (0781-5768-92)Marketed from Jan 14, 2026

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): Sitagliptin Phosphate
Generic name (nonproprietary): sitagliptin phosphate
Active ingredients: Sitagliptin phosphate — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202387
Marketing start: Jan 14, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0781-5768_dd07ef38-4a9b-46f4-90ed-dd520cc1d75eSPL ID dd07ef38-4a9b-46f4-90ed-dd520cc1d75eSPL set ID cebc8388-c9db-4e27-8d6b-0d9bdc9d766dRxCUI 2709603, 2709608, 2709612UNII TS63EW8X6F
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

N400781576831 followed by a unit qualifier and the quantity

Package 00781-5768-31. 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 May 10, 2026.

Indications (excerpt from the label)

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin tablets have 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 sitagliptin tablets. [See Warnings and Precautions ( 5.1 ).] Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5768

What is NDC 0781-5768?: 0781-5768 is the product NDC for Sitagliptin Phosphate, Sitagliptin phosphate 50 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sitagliptin Phosphate.
What is the active ingredient?: Sitagliptin phosphate.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sitagliptin Phosphate?: 2 other product NDCs are listed under this name. See all Sitagliptin Phosphate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sitagliptin Phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sitagliptin Phosphate	Sitagliptin phosphate 25 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5766	00781-5766-3100781-5766-92
Sitagliptin Phosphate	Sitagliptin phosphate 100 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5770	00781-5770-1000781-5770-3100781-5770-92

Other NDCs under ANDA 202387

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

FDA NDC Directory listings under ANDA 202387
Product	Strength	Form · route	Labeler	Product NDC
Sitagliptin Phosphate	Sitagliptin phosphate 25 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5766
Sitagliptin Phosphate	Sitagliptin phosphate 100 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5770