Tropicamide
(Sterile)
Approved
Approval ID
892b78c8-36bc-47d3-850e-502899b48fb9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2023
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 196603781
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tropicamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24208-590
Application NumberANDA040067
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tropicamide
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (7)
TROPICAMIDEActive
Quantity: 5 mg in 1 mL
Code: N0A3Z5XTC6
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Tropicamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24208-585
Application NumberANDA040064
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tropicamide
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (7)
TROPICAMIDEActive
Quantity: 10 mg in 1 mL
Code: N0A3Z5XTC6
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT