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Chlorothiazide

Chlorothiazide Sodium for Injection, USP

Approved
Approval ID

5b5d8a97-1428-4047-8e6c-b778429a26e4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 31, 2023

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 1

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

CHLOROTHIAZIDE SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-658
Application NumberANDA090896
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLOROTHIAZIDE SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2023
FDA Product Classification

INGREDIENTS (3)

MANNITOLInactive
Quantity: 250 mg in 18 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CHLOROTHIAZIDE SODIUMActive
Quantity: 500 mg in 18 mL
Code: SN86FG7N2K
Classification: ACTIM

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Chlorothiazide - FDA Drug Approval Details