NDC 0065-0741

Tetracaine Hydrochloride

Tetracaine Hydrochloride

Tetracaine Hydrochloride is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Tetracaine Hydrochloride.

Product ID0065-0741_02b341d7-93f6-4fde-a883-cdf4df6155b7
NDC0065-0741
Product TypeHuman Prescription Drug
Proprietary NameTetracaine Hydrochloride
Generic NameTetracaine Hydrochloride
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-10-26
Marketing CategoryNDA / NDA
Application NumberNDA208135
Labeler NameAlcon Laboratories, Inc.
Substance NameTETRACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesEster Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0065-0741-14

12 BLISTER PACK in 1 CARTON (0065-0741-14) > 1 BOTTLE, DROPPER in 1 BLISTER PACK > 4 mL in 1 BOTTLE, DROPPER
Marketing Start Date2016-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0741-12 [00065074112]

Tetracaine Hydrochloride SOLUTION
Marketing CategoryNDA
Application NumberNDA208135
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-26
Marketing End Date2016-10-26

NDC 0065-0741-14 [00065074114]

Tetracaine Hydrochloride SOLUTION
Marketing CategoryNDA
Application NumberNDA208135
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-26

Drug Details

Active Ingredients

IngredientStrength
TETRACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1547771
    • UPC Code
  • 0300650741149

    • Pharmacological Class

    • Esters [CS]
    • Local Anesthesia [PE]
    • Ester Local Anesthetic [EPC]

    NDC Crossover Matching brand name "Tetracaine Hydrochloride" or generic name "Tetracaine Hydrochloride"

    NDCBrand NameGeneric Name
    0065-0741Tetracaine Hydrochloridetetracaine hydrochloride
    0187-0920Tetracaine HydrochlorideTetracaine Hydrochloride
    24208-092Tetracaine HydrochlorideTetracaine Hydrochloride
    24208-920Tetracaine HydrochlorideTetracaine Hydrochloride
    42702-170Tetracaine HydrochlorideTetracaine Hydrochloride
    49999-268Tetracaine HydrochlorideTetracaine Hydrochloride
    66267-924Tetracaine HydrochlorideTetracaine Hydrochloride
    68071-4579Tetracaine HydrochlorideTetracaine Hydrochloride
    68071-5069Tetracaine HydrochlorideTetracaine Hydrochloride
    68071-5079Tetracaine Hydrochloridetetracaine hydrochloride
    68682-920Tetracaine HydrochlorideTetracaine Hydrochloride
    68788-0920Tetracaine HydrochlorideTetracaine Hydrochloride
    69292-317Tetracaine HydrochlorideTetracaine Hydrochloride
    70518-2224Tetracaine HydrochlorideTetracaine Hydrochloride
    70518-2741Tetracaine HydrochlorideTetracaine Hydrochloride
    76413-127Tetracaine HydrochlorideTetracaine Hydrochloride
    76519-1118TETRACAINE HYDROCHLORIDETETRACAINE HYDROCHLORIDE
    82260-920Tetracaine HydrochlorideTetracaine Hydrochloride
    59390-181ALTACAINETetracaine Hydrochloride
    42494-437TetracaineTETRACAINE HYDROCHLORIDE
    63629-9160TetracaineTETRACAINE HYDROCHLORIDE
    54799-505TetraViscTetracaine Hydrochloride
    54799-504TetraVisc ForteTetracaine Hydrochloride
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