NDC 0187-0920

Tetracaine Hydrochloride

Tetracaine Hydrochloride

Tetracaine Hydrochloride is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Tetracaine Hydrochloride.

Product ID0187-0920_78404c9e-9c31-4b0a-90f4-04182e82e183
NDC0187-0920
Product TypeHuman Prescription Drug
Proprietary NameTetracaine Hydrochloride
Generic NameTetracaine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-06-27
Marketing CategoryNDA / NDA
Application NumberNDA210821
Labeler NameBausch Health US LLC
Substance NameTETRACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesEsters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0187-0920-05

1 BOTTLE in 1 CARTON (0187-0920-05) > 5 mL in 1 BOTTLE
Marketing Start Date2020-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-0920-05 [00187092005]

Tetracaine Hydrochloride SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA210821
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-05

Drug Details

Active Ingredients

IngredientStrength
TETRACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:78404c9e-9c31-4b0a-90f4-04182e82e183
Manufacturer
UNII

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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