ATROPINE SULFATE
ATROPINE SULFATE INJECTION, USP 1mg/mL
Approved
Approval ID
0060b971-19bd-2849-e063-6294a90afca8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2024
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
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 Code51662-1626
Application NumberANDA216120
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATROPINE SULFATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 28, 2024
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ATROPINE SULFATEActive
Quantity: 1 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB