Saxagliptin NDC 65862-825

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-825Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0825Add 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
65862-825-01	65862082501	100 TABLET, FILM COATED in 1 BOTTLE (65862-825-01)Marketed from Jul 31, 2023
65862-825-05	65862082505	500 TABLET, FILM COATED in 1 BOTTLE (65862-825-05)Marketed from Jul 31, 2023
65862-825-30	65862082530	30 TABLET, FILM COATED in 1 BOTTLE (65862-825-30)Marketed from Jul 31, 2023
65862-825-90	65862082590	90 TABLET, FILM COATED in 1 BOTTLE (65862-825-90)Marketed from Jul 31, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Generic name (nonproprietary): saxagliptin
Active ingredients: Saxagliptin hydrochloride — 2.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205972
Marketing start: Jul 31, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 65862-825_ac9f5784-0c62-42f2-bc34-4cef2486b7f7SPL ID ac9f5784-0c62-42f2-bc34-4cef2486b7f7SPL set ID f3ea58bb-0002-4a5d-9213-7e9066e3dc9cRxCUI 858036, 858042UNII Z8J84YIX6LUPC 0365862825308, 0365862826305
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

N465862082501 followed by a unit qualifier and the quantity

Package 65862-0825-01. 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 Dec 4, 2024.

Indications (excerpt from the label)

Saxagliptin 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. ( 1.1 ) Limitations of use: Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.2 ) 1.1 Monotherapy and Combination Therapy Saxagliptin 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) ]. 1.2 Limitations of Use Saxagliptin tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205972

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

FDA NDC Directory listings under ANDA 205972
Product	Strength	Form · route	Labeler	Product NDC
Saxagliptin	Saxagliptin hydrochloride 5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-826