Actos
These highlights do not include all the information needed to use ACTOS safely and effectively. See full prescribing information for ACTOS. ACTOS (pioglitazone hydrochloride) tablets for oral useInitial U.S. Approval: 1999
Approved
Approval ID
2a97ef74-b338-4655-a60b-923f86720179
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pioglitazone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4354
Application NumberNDA021073
Product Classification
M
Marketing Category
C73594
G
Generic Name
pioglitazone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (5)
pioglitazone hydrochlorideActive
Quantity: 30 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIB
carboxymethylcellulose calciumInactive
Code: UTY7PDF93L
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
pioglitazone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4343
Application NumberNDA021073
Product Classification
M
Marketing Category
C73594
G
Generic Name
pioglitazone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (5)
carboxymethylcellulose calciumInactive
Code: UTY7PDF93L
Classification: IACT
pioglitazone hydrochlorideActive
Quantity: 15 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIB
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
pioglitazone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4391
Application NumberNDA021073
Product Classification
M
Marketing Category
C73594
G
Generic Name
pioglitazone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 24, 2012
FDA Product Classification
INGREDIENTS (5)
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
pioglitazone hydrochlorideActive
Quantity: 45 mg in 1 1
Code: JQT35NPK6C
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
carboxymethylcellulose calciumInactive
Code: UTY7PDF93L
Classification: IACT