Prescription drug · NDA AUTHORIZED GENERIC
Alogliptin NDC 45802-087
Alogliptin benzoate 6.25 mg/1 · Tablet, Film coated · Oral · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-087-65 | 4580200876545802008765 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-087-65)Marketed from Apr 8, 2016 |
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 — 6.25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- 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 45802-087_1287590b-abdf-470b-a611-dfb9bc93692aSPL ID 1287590b-abdf-470b-a611-dfb9bc93692aSPL set ID b25f155a-1259-47c2-aa3b-7c1356e4c7f6RxCUI 1368006, 1368018, 1368034UNII EEN99869SCUPC 0345802087652, 0345802103659, 0345802150653
- 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
N445802008765followed by a unit qualifier and the quantityPackage 45802-0087-65. 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. 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 mellitus. ( 1 ) Limitations of Use Alogliptin tablet is not recommended for use in patients with type 1 diabetes mellitus.
Excerpt only. Read the full label for complete information.
About NDC 45802-087
- What is NDC 45802-087?
- 45802-087 is the product NDC for Alogliptin, Alogliptin benzoate 6.25 mg/1 tablet, film coated, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alogliptin.
- What is the active ingredient?
- Alogliptin benzoate.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alogliptin?
- 6 other product NDCs are listed under this name. See all Alogliptin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alogliptin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-103 | 45802-0103-65 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-150 | 45802-0150-65 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5574 | 50090-5574-00 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4946 | 63629-4946-01 |
| Alogliptin | Alogliptin benzoate 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-300 | 71610-0300-0971610-0300-1871610-0300-60 |
| Alogliptin | Alogliptin benzoate 12.5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-661 | 71610-0661-0971610-0661-18 |
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 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 |
| Nesinaalogliptin | Alogliptin benzoate 6.25 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-625 |