tetracaine hydrochloride

Generic: tetracaine hydrochloride

Labeler: bausch health us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetracaine hydrochloride
Generic Name tetracaine hydrochloride
Labeler bausch health us llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tetracaine hydrochloride 5 mg/mL

Manufacturer
Bausch Health US LLC

Identifiers & Regulatory

Product NDC 0187-0920
Product ID 0187-0920_453da1ac-7306-7a40-e063-6394a90a741c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210821
Marketing Start 2019-06-27
Marketing End 2027-04-30

Pharmacologic Class

Classes
ester local anesthetic [epc] esters [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01870920
Hyphenated Format 0187-0920

Supplemental Identifiers

RxCUI
1547771
UNII
5NF5D4OPCI

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tetracaine hydrochloride (source: ndc)
Generic Name tetracaine hydrochloride (source: ndc)
Application Number NDA210821 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0187-0920-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

0187-0920-05 1 BOTTLE in 1 CARTON (0187-0920-05) / 5 mL in 1 BOTTLE

Ingredients (1)

tetracaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Tetracaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "453da1ac-7306-7a40-e063-6394a90a741c", "openfda": {"unii": ["5NF5D4OPCI"], "rxcui": ["1547771"], "spl_set_id": ["78404c9e-9c31-4b0a-90f4-04182e82e183"], "manufacturer_name": ["Bausch Health US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0187-0920-05)  / 5 mL in 1 BOTTLE", "package_ndc": "0187-0920-05", "marketing_end_date": "20270430", "marketing_start_date": "20190627"}], "brand_name": "Tetracaine Hydrochloride", "product_id": "0187-0920_453da1ac-7306-7a40-e063-6394a90a741c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "0187-0920", "generic_name": "Tetracaine Hydrochloride", "labeler_name": "Bausch Health US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetracaine Hydrochloride", "active_ingredients": [{"name": "TETRACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA210821", "marketing_category": "NDA", "marketing_end_date": "20270430", "marketing_start_date": "20190627"}