What is NDC 68462-727?

68462-727 is the product NDC for Saxagliptin, Saxagliptin hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 4 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Saxagliptin?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Saxagliptin NDC 68462-727 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-727Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0727Add 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
68462-727-05	6846207270568462072705	500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05)Marketed from Jul 31, 2023
68462-727-14	6846207271468462072714	10 BLISTER PACK in 1 CARTON (68462-727-14) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 31, 2023
68462-727-30	6846207273068462072730	30 TABLET, FILM COATED in 1 BOTTLE (68462-727-30)Marketed from Jul 31, 2023
68462-727-90	6846207279068462072790	90 TABLET, FILM COATED in 1 BOTTLE (68462-727-90)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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205994
Marketing start: Jul 31, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 68462-727_4d1a25c6-4ffc-4714-98a9-c4dcb2049d6dSPL ID 4d1a25c6-4ffc-4714-98a9-c4dcb2049d6dSPL set ID e286ffd4-c598-47fb-af06-2e15f7e6f99fRxCUI 858036, 858042UNII Z8J84YIX6L
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

N468462072705 followed by a unit qualifier and the quantity

Package 68462-0727-05. 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 Jan 27, 2026.

Indications (excerpt from the label)

Saxagliptin tablets are 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 Limitation 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)

About NDC 68462-727

What is NDC 68462-727?: 68462-727 is the product NDC for Saxagliptin, Saxagliptin hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Saxagliptin.
What is the active ingredient?: Saxagliptin hydrochloride.
Who is the labeler?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Saxagliptin?: 5 other product NDCs are listed under this name. See all Saxagliptin 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 Saxagliptin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Saxagliptin	Saxagliptin hydrochloride dihydrate 2.5 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-4705	00378-4705-7700378-4705-93
Saxagliptin	Saxagliptin hydrochloride dihydrate 5 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-4706	00378-4706-7700378-4706-93
Saxagliptin	Saxagliptin hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-825	65862-0825-0165862-0825-0565862-0825-30+1 more
Saxagliptin	Saxagliptin hydrochloride 5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-826	65862-0826-0165862-0826-0565862-0826-30+1 more
Saxagliptin	Saxagliptin hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-726	68462-0726-0568462-0726-3068462-0726-90

Other NDCs under ANDA 205994

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

FDA NDC Directory listings under ANDA 205994
Product	Strength	Form · route	Labeler	Product NDC
Saxagliptin	Saxagliptin hydrochloride 2.5 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-726