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
09d086f2-db9a-5e15-e063-6394a90abe18
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Medical Purchasing Solutions, LLC
DUNS: 601458529
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 Code71872-7312
Application NumberANDA216120
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATROPINE SULFATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.4 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB