Prescription drug · NDA
Kazano (Alogliptin and metformin hydrochloride) NDC 64764-335
Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-335-01 | 6476403350164764033501 | 4 CARTON in 1 TRAY (64764-335-01) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 25, 2013 | |
| 64764-335-60 | 6476403356064764033560 | 60 TABLET, FILM COATED in 1 BOTTLE (64764-335-60)Marketed from Jan 25, 2013 | |
| 64764-335-77 | 6476403357764764033577 | 500 TABLET, FILM COATED in 1 BOTTLE (64764-335-77)Marketed from Jan 25, 2013 | |
| 64764-335-80 | 6476403358064764033580 | 180 TABLET, FILM COATED in 1 BOTTLE (64764-335-80)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)
- Kazano
- Generic name (nonproprietary)
- alogliptin and metformin hydrochloride
- Active ingredients
- Alogliptin benzoate — 12.5 mg/1Metformin hydrochloride — 500 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 203414
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 64764-335_699d63c4-18d5-47a8-98d6-680cb351bbbeSPL ID 699d63c4-18d5-47a8-98d6-680cb351bbbeSPL set ID 83cb7914-a683-47bb-a713-f2bc6a596bd2RxCUI 1368385, 1368391, 1368392, 1368398UNII 786Z46389E, EEN99869SCUPC 0364764335601
- Pharmacologic class
- Biguanide; 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
N464764033501followed by a unit qualifier and the quantityPackage 64764-0335-01. 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)
KAZANO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. KAZANO is a combination of alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, 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 KAZANO is not recommended for use in patients with type 1 diabetes mellitus.
Excerpt only. Read the full label for complete information.
About NDC 64764-335
- What is NDC 64764-335?
- 64764-335 is the product NDC for Kazano, Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kazano (Alogliptin and metformin hydrochloride).
- What is the active ingredient?
- Alogliptin benzoate, Metformin hydrochloride.
- 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 Kazano?
- 1 other product NDC are listed under this name. See all Kazano NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kazano products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kazanoalogliptin and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-337 | 64764-0337-0164764-0337-6064764-0337-77+1 more |
Other NDCs under NDA 203414
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 and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-169 |
| alogliptin and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Padagis Israel Pharmaceuticals Ltd | 45802-211 |
| alogliptin and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5993 |
| Kazanoalogliptin and metformin hydrochloride | Alogliptin benzoate 12.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-337 |