What is NDC 0781-5801?

0781-5801 is the product NDC for Sitagliptin and Metformin Hydrochloride, Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Sitagliptin phosphate, Metformin hydrochloride.

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 and Metformin Hydrochloride?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sitagliptin and Metformin Hydrochloride NDC 0781-5801

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5801Add 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
0781-5801-05	0078158010500781580105	500 TABLET, FILM COATED in 1 BOTTLE (0781-5801-05)Marketed from Dec 2, 2025
0781-5801-60	0078158016000781580160	60 TABLET, FILM COATED in 1 BOTTLE (0781-5801-60)Marketed from Dec 2, 2025
0781-5801-71	0078158017100781580171	180 TABLET, FILM COATED in 1 BOTTLE (0781-5801-71)Marketed from Dec 2, 2025

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 and Metformin Hydrochloride
Generic name (nonproprietary): sitagliptin and metformin hydrochloride
Active ingredients: Sitagliptin phosphate — 50 mg/1Metformin hydrochloride — 500 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 202388
Marketing start: Dec 2, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0781-5801_a0fcdc08-0afc-4912-a126-3efea6bc8c61SPL ID a0fcdc08-0afc-4912-a126-3efea6bc8c61SPL set ID a0fcdc08-0afc-4912-a126-3efea6bc8c61RxCUI 2709488, 2709491UNII 786Z46389E, TS63EW8X6FUPC 0307815801601
Pharmacologic class: Biguanide; 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

N400781580105 followed by a unit qualifier and the quantity

Package 00781-5801-05. 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 Sep 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Sitagliptin and metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin and metformin hydrochloride should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride 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 and metformin hydrochloride. [see Warnings and Precautions ( 5.2 )] Sitagliptin and metformin hydrochloride tablets are a combination of sitagliptin, a dipeptidyl peptidase…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5801

What is NDC 0781-5801?: 0781-5801 is the product NDC for Sitagliptin and Metformin Hydrochloride, Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sitagliptin and Metformin Hydrochloride.
What is the active ingredient?: Sitagliptin phosphate, Metformin hydrochloride.
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 and Metformin Hydrochloride?: 18 other product NDCs are listed under this name. See all Sitagliptin and Metformin Hydrochloride 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 and Metformin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sitagliptin and Metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Par Health USA, LLC	10370-317	10370-0317-02
Sitagliptin and Metformin hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Par Health USA, LLC	10370-318	10370-0318-02
Sitagliptin and Metformin hydrochloride	Sitagliptin phosphate 100 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Par Health USA, LLC	10370-351	10370-0351-11
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3658	60505-3658-0660505-3658-07
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3659	60505-3659-0660505-3659-07
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-052	84677-0052-1884677-0052-60
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	84677-053	84677-0053-1884677-0053-60
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5802	00781-5802-6000781-5802-7100781-5802-73
Sitagliptin and Metformin Hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-2036	70710-2036-06
Sitagliptin and Metformin Hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-2037	70710-2037-06

All 19 Sitagliptin and Metformin Hydrochloride NDCs

Other NDCs under ANDA 202388

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

FDA NDC Directory listings under ANDA 202388
Product	Strength	Form · route	Labeler	Product NDC
Sitagliptin and Metformin Hydrochloride	Sitagliptin phosphate 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5802