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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
March 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Prazosin(1 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Quality Care Products, LLC

Quality Care Products, LLC

831276758

Products1

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
55700-492
Application Number
ANDA071745
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 1, 2023
PrazosinActive
Code: X0Z7454B90Class: ACTIMQuantity: 1 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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