Atropine Sulfate
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous, intramuscular, subcutaneous, intraosseous or endotracheal use. Initial U.S. Approval: 1960
Approved
Approval ID
0aab13de-04bf-2a14-e063-6294a90aae11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 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 Code71872-7316
Application NumberANDA213561
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atropine Sulfate
Product Specifications
Route of AdministrationENDOTRACHEAL, INTRAMEDULLARY, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.4 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB