Chlorothiazide
Chlorothiazide Sodium for Injection, USP
Approved
Approval ID
de512e9b-444c-4ae4-8c6b-accd87a02021
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 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 DateJuly 10, 2017
FDA Product Classification
INGREDIENTS (3)
MANNITOLInactive
Quantity: 250 mg in 18 mL
Code: 3OWL53L36A
Classification: IACT
CHLOROTHIAZIDE SODIUMActive
Quantity: 500 mg in 18 mL
Code: SN86FG7N2K
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT