Duetact is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Glimepiride; Pioglitazone Hydrochloride.
| Product ID | 64764-304_053856e0-af50-49c3-94f4-b214ed766bd1 |
| NDC | 64764-304 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Duetact |
| Generic Name | Pioglitazone And Glimepiride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2006-07-28 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021925 |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Substance Name | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE |
| Active Ingredient Strength | 4 mg/1; mg/1 |
| Pharm Classes | PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Sulfonylurea Compounds [CS], Sulfonylurea [EPC], Thiazolidinedione [EPC], Thiazolidinediones [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2006-07-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA021925 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2006-07-28 |
| Marketing Category | NDA |
| Application Number | NDA021925 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2006-07-28 |
| Ingredient | Strength |
|---|---|
| PIOGLITAZONE HYDROCHLORIDE | 30 mg/1 |
| SPL SET ID: | f8b0c917-3fdd-4a28-a47d-6225b8195458 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 64764-302 | Duetact | pioglitazone and glimepiride |
| 64764-304 | Duetact | pioglitazone and glimepiride |
| 66993-821 | pioglitazone and glimepiride | pioglitazone and glimepiride |
| 66993-822 | pioglitazone and glimepiride | pioglitazone and glimepiride |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DUETACT 78711899 3299312 Live/Registered |
Takeda Pharmaceutical Company Limited 2005-09-13 |