Atropine Sulfate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for Initial U.S. Approval: 1960
Approved
Approval ID
4a9559e8-7a34-4509-a8cc-ff0125694539
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 5, 2023
Manufacturers
FDA
Henry Schein, Inc.
DUNS: 012430880
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atropine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-9989
Application NumberNDA214652
Product Classification
M
Marketing Category
C73594
G
Generic Name
Atropine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 5, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ATROPINE SULFATEActive
Quantity: 1 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT