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NDC 64764-0123-05 OSENI 12.5; 30 mg/1; mg/1 Details
OSENI 12.5; 30 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 | 64764-0123 |
|---|---|
| Product ID | 64764-123_2132de34-57ee-4ffa-8c28-a085d533f8aa |
| Associated GPIs | 27994002100325 |
| GCN Sequence Number | 070522 |
| GCN Sequence Number Description | alogliptin benz/pioglitazone TABLET 12.5-30 MG ORAL |
| HIC3 | C4C |
| HIC3 Description | ANTIHYPERGLY,DPP-4 ENZYME INHIB.-THIAZOLIDINEDIONE |
| GCN | 34083 |
| 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; 30 |
| 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], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], P |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022426 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64764-0123-05 (64764012305)
| NDC Package Code | 64764-123-05 |
|---|---|
| Billing NDC | 64764012305 |
| Package | 500 TABLET, FILM COATED in 1 BOTTLE (64764-123-05) |
| Marketing Start Date | 2013-01-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |