MedPath

Prazosin Hydrochloride

406740684069

Approved
Approval ID

1dbfa041-7ca4-4fce-b992-286e4354e6c6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 1, 2023

Manufacturers
FDA

Quality Care Products, LLC

DUNS: 831276758

Products 1

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 Code55700-492
Application NumberANDA071745
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prazosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2023
FDA Product Classification

INGREDIENTS (6)

PRAZOSIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: X0Z7454B90
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Prazosin Hydrochloride - FDA Drug Approval Details