duetact

Generic: pioglitazone and glimepiride

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name duetact
Generic Name pioglitazone and glimepiride
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

glimepiride 4 mg/1, pioglitazone hydrochloride 30 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-304
Product ID 64764-304_23f68487-5d22-4618-9ccc-417aeb9fd3a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021925
Listing Expiration 2026-12-31
Marketing Start 2006-07-28

Pharmacologic Class

Established (EPC)
sulfonylurea [epc]
Chemical Structure
sulfonylurea compounds [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764304
Hyphenated Format 64764-304

Supplemental Identifiers

RxCUI
647237 647239 731457 731463
UPC
0364764302306 0364764304300
UNII
JQT35NPK6C 6KY687524K
NUI
N0000175608 M0020795

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name duetact (source: ndc)
Generic Name pioglitazone and glimepiride (source: ndc)
Application Number NDA021925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (64764-304-30)
  • 90 TABLET in 1 BOTTLE (64764-304-90)
source: ndc

Packages (2)

64764-304-30 30 TABLET in 1 BOTTLE (64764-304-30) 64764-304-90 90 TABLET in 1 BOTTLE (64764-304-90)

Ingredients (2)

glimepiride (4 mg/1) pioglitazone hydrochloride (30 mg/1)

Linked Drug Pages (1)

Duetact ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "23f68487-5d22-4618-9ccc-417aeb9fd3a8", "openfda": {"nui": ["N0000175608", "M0020795"], "upc": ["0364764302306", "0364764304300"], "unii": ["JQT35NPK6C", "6KY687524K"], "rxcui": ["647237", "647239", "731457", "731463"], "spl_set_id": ["f8b0c917-3fdd-4a28-a47d-6225b8195458"], "pharm_class_cs": ["Sulfonylurea Compounds [CS]"], "pharm_class_epc": ["Sulfonylurea [EPC]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (64764-304-30)", "package_ndc": "64764-304-30", "marketing_start_date": "20060728"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (64764-304-90)", "package_ndc": "64764-304-90", "marketing_start_date": "20060728"}], "brand_name": "Duetact", "product_id": "64764-304_23f68487-5d22-4618-9ccc-417aeb9fd3a8", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]", "Peroxisome Proliferator Receptor gamma Agonist [EPC]", "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]", "Peroxisome Proliferator-activated Receptor gamma Agonists [MoA]", "Sulfonylurea Compounds [CS]", "Sulfonylurea [EPC]", "Thiazolidinedione [EPC]", "Thiazolidinediones [CS]"], "product_ndc": "64764-304", "generic_name": "pioglitazone and glimepiride", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duetact", "active_ingredients": [{"name": "GLIMEPIRIDE", "strength": "4 mg/1"}, {"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA021925", "marketing_category": "NDA", "marketing_start_date": "20060728", "listing_expiration_date": "20261231"}