Atropine Sulfate
These highlights do not include all the information needed to use ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1% safely and effectively. See full prescribing information for ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%. ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%, for topical ophthalmic useInitial U.S. Approval: 1960
Approved
Approval ID
aeab333c-3cdb-45c0-9e22-949624d69fbc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2022
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 196603781
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 Code24208-965
Application NumberNDA213581
Product Classification
M
Marketing Category
C73594
G
Generic Name
Atropine Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 3, 2022
FDA Product Classification
INGREDIENTS (6)
ATROPINE SULFATEActive
Quantity: 10 mg in 1 mL
Code: 03J5ZE7KA5
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT