Prazosin Hydrochloride
Prazosin Hydrochloride Capsules, USP.
Approved
Approval ID
cdde7b22-6b29-4cac-8bd6-f613dab6eef1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2023
Manufacturers
FDA
Exelan Pharmaceuticals
DUNS: 967795266
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prazosin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-721
Application NumberANDA214608
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2023
FDA Product Classification
INGREDIENTS (11)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PRAZOSIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Prazosin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-722
Application NumberANDA214608
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2023
FDA Product Classification
INGREDIENTS (13)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PRAZOSIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
Prazosin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-723
Application NumberANDA214608
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2023
FDA Product Classification
INGREDIENTS (13)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PRAZOSIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT