Prescription drug · NDA
Oseni NDC 64764-254
alogliptin and pioglitazone · Alogliptin benzoate 25 mg/1; Pioglitazone hydrochloride 45 mg/1 · Tablet, Film coated · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-254-03 | 64764025403 | 30 TABLET, FILM COATED in 1 BOTTLE (64764-254-03)Marketed from Jan 25, 2013 | |
| 64764-254-04 | 64764025404 | 90 TABLET, FILM COATED in 1 BOTTLE (64764-254-04)Marketed from Jan 25, 2013 | |
| 64764-254-05 | 64764025405 | 500 TABLET, FILM COATED in 1 BOTTLE (64764-254-05)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 — 45 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022426
- Marketing start
- Listing expires
- 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 64764-254_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
N464764025403followed by a unit qualifier and the quantityPackage 64764-0254-03. 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 . 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.
Other NDCs under NDA 022426
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 15 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-251 |
| 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 |