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Tetracaine

TETRACAINE 1% Tetracaine HCl Injection, USP for Prolonged Spinal Anesthesia

Approved
Approval ID

fd45e843-e5ee-4fd7-b11d-108fb76d9d96

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 12, 2024

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code63629-9160
Product Classification
G
Generic Name
TETRACAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TETRACAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 5NF5D4OPCI
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Tetracaine - FDA Drug Approval Details