Tetracaine Hydrochloride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval:
Approved
Approval ID
807dae5d-f34a-4f3d-9f54-dd350b056a92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2022
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
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 Code68682-920
Application NumberNDA210821
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tetracaine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (8)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TETRACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 5NF5D4OPCI
Classification: ACTIB
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT