What is NDC 70710-2038?

70710-2038 is the product NDC for Sitagliptin and Metformin Hydrochloride, Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Sitagliptin, Metformin hydrochloride.

Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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 70710-2038

NDC codes

FDA NDC Directory

Product NDC (as listed)70710-2038Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70710-2038Add 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
70710-2038-3	7071020380370710203803	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-2038-3)Marketed from Oct 31, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 216778
Marketing start: Oct 31, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 70710-2038_8898638c-e4b3-4fdf-91e6-d39156e5ace9SPL ID 8898638c-e4b3-4fdf-91e6-d39156e5ace9SPL set ID d3a728a0-decb-4340-8ee4-c5e27c13eb19RxCUI 1243827, 1243842, 1243846UNII 786Z46389E, QFP0P1DV7Z
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

N470710203803 followed by a unit qualifier and the quantity

Package 70710-2038-03. 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 Aug 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Sitagliptin and metformin hydrochloride extended-release 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 and metformin hydrochloride extended-release tablets are not recommended in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride extended-release 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 and metformin hydrochloride extended-release tablets [see Warnings and Precautions ( 5.2 )]. Si…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70710-2038

What is NDC 70710-2038?: 70710-2038 is the product NDC for Sitagliptin and Metformin Hydrochloride, Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, 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, Metformin hydrochloride.
Who is the labeler?: Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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 500 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5801	00781-5801-0500781-5801-6000781-5801-71
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

All 19 Sitagliptin and Metformin Hydrochloride NDCs

Other NDCs under NDA 216778

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

FDA NDC Directory listings under NDA 216778
Product	Strength	Form · route	Labeler	Product NDC
Sitagliptin and Metformin Hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-2036
Sitagliptin and Metformin Hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-2037
Sitagliptin and Metformin Hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1886
Sitagliptin and Metformin Hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1887
Sitagliptin and Metformin Hydrochloride	Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1888
Zituvimet XRsitagliptin and metformin hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1804
Zituvimet XRsitagliptin and metformin hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1805
Zituvimet XRsitagliptin and metformin hydrochloride	Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1806
Zituvimet XRsitagliptin and metformin hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1879
Zituvimet XRsitagliptin and metformin hydrochloride	Sitagliptin 50 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1880
Zituvimet XRsitagliptin and metformin hydrochloride	Sitagliptin 100 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1881