Oseni NDC 64764-251

NDC codes

FDA NDC Directory

Product NDC (as listed)64764-251Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64764-0251Add 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
64764-251-03	64764025103	30 TABLET, FILM COATED in 1 BOTTLE (64764-251-03)Marketed from Jan 25, 2013
64764-251-04	64764025104	90 TABLET, FILM COATED in 1 BOTTLE (64764-251-04)Marketed from Jan 25, 2013
64764-251-05	64764025105	500 TABLET, FILM COATED in 1 BOTTLE (64764-251-05)Marketed from Jan 25, 2013

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): Oseni
Generic name (nonproprietary): alogliptin and pioglitazone
Active ingredients: Alogliptin benzoate — 25 mg/1Pioglitazone hydrochloride — 15 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Takeda Pharmaceuticals America, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022426
Marketing start: Jan 25, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Dipeptidyl Peptidase 4 Inhibitors (Mechanism)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 64764-251_2346b7f5-b2c1-45f0-9f8f-5cbb4b202857SPL ID 2346b7f5-b2c1-45f0-9f8f-5cbb4b202857SPL set ID 4c619ed9-fe3e-4158-9938-80c6c3493d55RxCUI 1368410, 1368416, 1368424, 1368430, 1368431, 1368437, 1368438, 1368444UNII EEN99869SC, JQT35NPK6CUPC 0364764251031, 0364764253035, 0364764254032, 0364764123031
Pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor; Peroxisome Proliferator Receptor alpha Agonist; Peroxisome Proliferator Receptor gamma Agonist; Thiazolidinedione

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

N464764025103 followed by a unit qualifier and the quantity

Package 64764-0251-03. 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 Feb 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. OSENI is a combination of alogliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: OSENI is not recommended for use in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use OSENI is not recommended for use in patients with type 1 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022426

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

FDA NDC Directory listings under NDA 022426
Product	Strength	Form · route	Labeler	Product NDC
Osenialogliptin and pioglitazone	Alogliptin benzoate 12.5 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-123
Osenialogliptin and pioglitazone	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 45 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-254
Osenialogliptin and pioglitazone	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	64764-253
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 12.5 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-260
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 15 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-351
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 30 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-402
Alogliptin and Pioglitazonealogliptin benzoate and pioglitazone hydrochloride	Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 45 mg/1	Tablet, Film coatedOral	Padagis Israel Pharmaceuticals Ltd	45802-499