prazosin hydrochloride
Prazosin Hydrochloride Capsules, USP
Approved
Approval ID
486d4f26-60ae-4e6c-aa36-0b298a7f9aed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 16, 2025
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
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 Code72205-276
Application NumberANDA216727
Product Classification
M
Marketing Category
C73584
G
Generic Name
prazosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2025
FDA Product Classification
INGREDIENTS (13)
PRAZOSIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
prazosin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-275
Application NumberANDA216727
Product Classification
M
Marketing Category
C73584
G
Generic Name
prazosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2025
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PRAZOSIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
prazosin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-277
Application NumberANDA216727
Product Classification
M
Marketing Category
C73584
G
Generic Name
prazosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2025
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PRAZOSIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/16/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/16/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/16/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/16/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/16/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/16/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/16/2025
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 4/16/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/16/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/16/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/16/2025