CHLOROTHIAZIDE SODIUM
Chlorothiazide Sodium for Injection, USP FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS
Approved
Approval ID
187240e9-1eed-45ec-befb-18647d175112
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code47335-330
Application NumberANDA091546
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLOROTHIAZIDE SODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 1, 2019
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