Tetracaine Hydrochloride
These highlights do not include all the information needed to use TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5% safely and effectively. See full prescribing information for TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5%.TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5%, for topical ophthalmic use Initial U.S. Approval: 1965
Approved
Approval ID
f12d5944-0d6c-43ff-89fd-e0b5669e9b4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2022
Manufacturers
FDA
Bausch & Lomb Americas Inc.
DUNS: 118287629
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tetracaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82260-920
Application NumberNDA210821
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tetracaine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 1, 2022
FDA Product Classification
INGREDIENTS (8)
TETRACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 5NF5D4OPCI
Classification: ACTIB
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
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