Prescription drug · NDA AUTHORIZED GENERIC
Alogliptin NDC 71610-300
Alogliptin benzoate 25 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-300-09 | 71610030009 | 9000 TABLET, FILM COATED in 1 BOTTLE (71610-300-09)Marketed from Jul 3, 2019 | |
| 71610-300-18 | 71610030018 | 3000 TABLET, FILM COATED in 1 BOTTLE (71610-300-18)Marketed from Jan 25, 2022 | |
| 71610-300-60 | 71610030060 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-300-60)Marketed from Feb 2, 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)
- Alogliptin
- Generic name (nonproprietary)
- alogliptin
- Active ingredients
- Alogliptin benzoate — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022271
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-300_a8ff5402-3a49-4f04-9868-f8b2dff3aa99SPL ID a8ff5402-3a49-4f04-9868-f8b2dff3aa99SPL set ID 4b007011-547a-498e-b8f6-34ea4ea00eb4RxCUI 1368006UNII EEN99869SC
- 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
N471610030009followed by a unit qualifier and the quantityPackage 71610-0300-09. 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)
Alogliptin 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) ]. Alogliptin 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 ) Limitations of Use: Should not be used in patients with type 1 diabetes. ( 1 ) Limitations of Use Alogliptin tablets should not be used in patients with type 1 diabetes mellitus.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022271
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 |
|---|---|---|---|---|
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4946 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5574 |
| Alogliptin | Alogliptin benzoate 6.25 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-087 |
| Nesinaalogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-125 |
| Alogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-103 |
| Nesinaalogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-250 |
| Nesinaalogliptin | Alogliptin benzoate 6.25 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-625 |
| Alogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-661 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-150 |