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FDA Approval

Prazosin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 3, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Prazosin(1 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Prazosin Hydrochloride

Product Details

NDC Product Code
51079-630
Application Number
ANDA072575
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 3, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
PrazosinActive
Code: X0Z7454B90Class: ACTIMQuantity: 1 mg in 1 1
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT

Prazosin Hydrochloride

Product Details

NDC Product Code
51079-631
Application Number
ANDA072575
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 3, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
PrazosinActive
Code: X0Z7454B90Class: ACTIMQuantity: 2 mg in 1 1
SHELLACInactive
Code: 46N107B71OClass: IACT

Prazosin Hydrochloride

Product Details

NDC Product Code
51079-632
Application Number
ANDA072575
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 3, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
PrazosinActive
Code: X0Z7454B90Class: ACTIMQuantity: 5 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION

The dose of prazosin hydrochloride capsules should be adjusted according to the patient’s individual blood pressure response. The following is a guide to its administration:

Initial Dose

1 mg two or three times a day (see WARNINGS).

Maintenance Dose

Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses. Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a daily dose of 40 mg given in divided doses. After initial titration some patients can be maintained adequately on a twice daily dosage regimen.

Use With Other Drugs

When adding a diuretic or other antihypertensive agent, the dose of prazosin hydrochloride capsules should be reduced to 1 mg or 2 mg three times a day and retitration then carried out.

Concomitant administration of prazosin hydrochloride capsules with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension; therefore, PDE-5 inhibitor therapy should be initiated at the lowest dose in patients taking prazosin hydrochloride capsules.


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