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NDC 64764-0124-03 OSENI 12.5; 45 mg/1; mg/1 Details
OSENI 12.5; 45 mg/1; mg/1
OSENI 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; PIOGLITAZONE HYDROCHLORIDE.
Product Information
| NDC | 64764-0124 |
|---|---|
| Product ID | 64764-124_ddffe5eb-c576-4c7f-89e7-0b20c7468d2f |
| Associated GPIs | 27994002100330 |
| GCN Sequence Number | 070523 |
| GCN Sequence Number Description | alogliptin benz/pioglitazone TABLET 12.5-45 MG ORAL |
| HIC3 | C4C |
| HIC3 Description | ANTIHYPERGLY,DPP-4 ENZYME INHIB.-THIAZOLIDINEDIONE |
| GCN | 34084 |
| HICL Sequence Number | 039967 |
| HICL Sequence Number Description | ALOGLIPTIN BENZOATE/PIOGLITAZONE HCL |
| Brand/Generic | Brand |
| Proprietary Name | OSENI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | alogliptin and pioglitazone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 45 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Pharmaceutical Class | Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activate |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022426 |
| Listing Certified Through | 2023-12-31 |
Package
NDC 64764-0124-03 (64764012403)
| NDC Package Code | 64764-124-03 |
|---|---|
| Billing NDC | 64764012403 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (64764-124-03) |
| Marketing Start Date | 2013-01-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |