Terazosin
TERAZOSIN CAPSULES, USP
Approved
Approval ID
5a1fe098-7006-48aa-a878-805c538116c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2015
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terazosin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-1056
Application NumberANDA075317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2015
FDA Product Classification
INGREDIENTS (9)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TERAZOSIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: D32S14F082
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT