Prescription drug · NDA AUTHORIZED GENERIC
Alogliptin NDC 71610-661
Alogliptin benzoate 12.5 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-661-09 | 71610066109 | 9000 TABLET, FILM COATED in 1 BOTTLE (71610-661-09)Marketed from Sep 8, 2022 | |
| 71610-661-18 | 71610066118 | 3000 TABLET, FILM COATED in 1 BOTTLE (71610-661-18)Marketed from Oct 17, 2022 |
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 — 12.5 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 71610-661_7ecf7f4e-e65c-4dde-9db9-20a170a427c9SPL ID 7ecf7f4e-e65c-4dde-9db9-20a170a427c9SPL set ID a05d6d17-79f9-4788-a4d5-467bca1a2d91RxCUI 1368034UNII 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
N471610066109followed by a unit qualifier and the quantityPackage 71610-0661-09. 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 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 , 14 ) Important Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1.1 ) 1.1 Monotherapy and Combination Therapy 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) ]. Important Limitations of Use Alogliptin tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.…
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 25 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-150 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-300 |