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NDC 64764-0337-80 KAZANO 12.5; 1000 mg/1; mg/1 Details
KAZANO 12.5; 1000 mg/1; mg/1
KAZANO is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE.
Product Information
| NDC | 64764-0337 |
|---|---|
| Product ID | 64764-337_7e03a27c-c802-48a0-801c-785f55f1df36 |
| Associated GPIs | 27992502100330 |
| GCN Sequence Number | 070527 |
| GCN Sequence Number Description | alogliptin benz/metformin HCl TABLET 12.5-1000 ORAL |
| HIC3 | C4F |
| HIC3 Description | ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS. |
| GCN | 34088 |
| HICL Sequence Number | 039970 |
| HICL Sequence Number Description | ALOGLIPTIN BENZOATE/METFORMIN HCL |
| Brand/Generic | Brand |
| Proprietary Name | KAZANO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | alogliptin and metformin hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 1000 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA203414 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64764-0337-80 (64764033780)
| NDC Package Code | 64764-337-80 |
|---|---|
| Billing NDC | 64764033780 |
| Package | 180 TABLET, FILM COATED in 1 BOTTLE (64764-337-80) |
| Marketing Start Date | 2013-01-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |