Prazosin hydrochloride
For Oral Use
Approved
Approval ID
82a84f69-4742-453f-96c8-532fb7df44c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2023
Manufacturers
FDA
Biocon Pharma Inc.
DUNS: 080000063
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 Code70377-066
Application NumberANDA213406
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prazosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (11)
PRAZOSIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Prazosin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-068
Application NumberANDA213406
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prazosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PRAZOSIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Prazosin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-067
Application NumberANDA213406
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prazosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2023
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PRAZOSIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT