ATROPINE SULFATE
ATROPINE SULFATE INJECTION, USP 1mg/10mL (0.1mg/mL) 10mL SYR
Approved
Approval ID
c0d0ca2a-4267-41b7-e053-2a95a90a4726
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 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 Code51662-1527
Application NumberANDA212461
Product Classification
M
Marketing Category
C73584
G
Generic Name
ATROPINE SULFATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (4)
ATROPINE SULFATEActive
Quantity: 0.1 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT