Prescription drug · NDA
Nesina (Alogliptin) NDC 64764-625
Alogliptin benzoate 6.25 mg/1 · Tablet, Film coated · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-625-30 | 6476406253064764062530 | 30 TABLET, FILM COATED in 1 BOTTLE (64764-625-30)Marketed from Jan 25, 2013 | |
| 64764-625-90 | 6476406259064764062590 | 90 TABLET, FILM COATED in 1 BOTTLE (64764-625-90)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)
- Nesina
- Generic name (nonproprietary)
- alogliptin
- Active ingredients
- Alogliptin benzoate — 6.25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 64764
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022271
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 64764-625_225103de-a3f2-47ee-bebb-4aa24b16aab4SPL ID 225103de-a3f2-47ee-bebb-4aa24b16aab4SPL set ID a3768c7e-aa4c-44d3-bc53-43bb7346c0b0RxCUI 1368006, 1368012, 1368018, 1368020, 1368034, 1368036UNII EEN99869SCUPC 0364764125301, 0364764625306, 0364764250300
- 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
N464764062530followed by a unit qualifier and the quantityPackage 64764-0625-30. 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)
NESINA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. NESINA is 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 mellitus. ( 1 ) Limitations of Use NESINA is not recommended for use in patients with type 1 diabetes mellitus.
Excerpt only. Read the full label for complete information.
About NDC 64764-625
- What is NDC 64764-625?
- 64764-625 is the product NDC for Nesina (alogliptin), Alogliptin benzoate 6.25 mg/1 tablet, film coated, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nesina (Alogliptin).
- What is the active ingredient?
- Alogliptin benzoate.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 64764. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nesina?
- 2 other product NDCs are listed under this name. See all Nesina NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nesina products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nesinaalogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-125 | 64764-0125-0264764-0125-3064764-0125-50+1 more |
| Nesinaalogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-250 | 64764-0250-0264764-0250-3064764-0250-50+1 more |
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 6.25 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-087 |
| Alogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-103 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-150 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5574 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4946 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-300 |
| Alogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-661 |
| Nesinaalogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-125 |
| Nesinaalogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-250 |