NDC codes

FDA NDC Directory
Product NDC (as listed)68462-726Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0726Add 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 NDC11-digit (billing)PackageCopy
68462-726-056846207260568462072605500 TABLET, FILM COATED in 1 BOTTLE (68462-726-05)Marketed from Jul 31, 2023
68462-726-30684620726306846207263030 TABLET, FILM COATED in 1 BOTTLE (68462-726-30)Marketed from Jul 31, 2023
68462-726-90684620726906846207269090 TABLET, FILM COATED in 1 BOTTLE (68462-726-90)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
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205994
Marketing start
Listing expires
Other FDA classes
Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers
Product ID 68462-726_4d1a25c6-4ffc-4714-98a9-c4dcb2049d6dSPL ID 4d1a25c6-4ffc-4714-98a9-c4dcb2049d6dSPL set ID e286ffd4-c598-47fb-af06-2e15f7e6f99fRxCUI 858036, 858042UNII Z8J84YIX6L

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

N468462072605 followed by a unit qualifier and the quantity

Package 68462-0726-05. 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 .

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 68462-726

What is NDC 68462-726?
68462-726 is the product NDC for Saxagliptin, Saxagliptin hydrochloride 2.5 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SaxagliptinSaxagliptin hydrochloride dihydrate 2.5 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-470500378-4705-7700378-4705-93
SaxagliptinSaxagliptin hydrochloride dihydrate 5 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.0378-470600378-4706-7700378-4706-93
SaxagliptinSaxagliptin hydrochloride 2.5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-82565862-0825-0165862-0825-0565862-0825-30+1 more
SaxagliptinSaxagliptin hydrochloride 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-82665862-0826-0165862-0826-0565862-0826-30+1 more
SaxagliptinSaxagliptin hydrochloride 5 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-72768462-0727-0568462-0727-1468462-0727-30+1 more

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
ProductStrengthForm · routeLabelerProduct NDC
SaxagliptinSaxagliptin hydrochloride 5 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-727

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