Saxagliptin and Metformin NDC 0378-8176

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8176Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8176Add 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
0378-8176-91	00378817691	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8176-91)Marketed from Aug 8, 2023

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): Saxagliptin and Metformin
Generic name (nonproprietary): saxagliptin and metformin
Active ingredients: Saxagliptin hydrochloride dihydrate — 2.5 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205981
Marketing start: Aug 8, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0378-8176_a865099b-37f9-4271-902c-6efd58fbc6c5SPL ID a865099b-37f9-4271-902c-6efd58fbc6c5SPL set ID cbf8677c-cafe-48bc-8844-0cc6547886bdRxCUI 1043563, 1043570, 1043578UNII 786Z46389E, 4N19ON48ZNUPC 0303788176913
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

N400378817691 followed by a unit qualifier and the quantity

Package 00378-8176-91. 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 21, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Saxagliptin 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 [ see Clinical Studies (14) ]. Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin hydrochloride (HCl), a biguanide, 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 the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.1 ) 1.1 Limitations of Use Saxagliptin and metformin hydrochlor…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205981

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

FDA NDC Directory listings under ANDA 205981
Product	Strength	Form · route	Labeler	Product NDC
Saxagliptin and Metformin	Saxagliptin hydrochloride dihydrate 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-8175
Saxagliptin and Metformin	Saxagliptin hydrochloride dihydrate 5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Mylan Pharmaceuticals Inc.	0378-8177