tetracaine hydrochloride

Generic: tetracaine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetracaine hydrochloride
Generic Name tetracaine hydrochloride
Labeler a-s medication solutions
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

tetracaine hydrochloride 5 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-2364
Product ID 50090-2364_c7b72c56-5267-471a-8370-55a0f0122e5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208135
Listing Expiration 2026-12-31
Marketing Start 2016-11-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500902364
Hyphenated Format 50090-2364

Supplemental Identifiers

RxCUI
1547771
UNII
5NF5D4OPCI

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 NDA208135 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 4 mL in 1 BOTTLE, DROPPER (50090-2364-1)
source: ndc

Packages (1)

50090-2364-1 4 mL in 1 BOTTLE, DROPPER (50090-2364-1)

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": "c7b72c56-5267-471a-8370-55a0f0122e5f", "openfda": {"unii": ["5NF5D4OPCI"], "rxcui": ["1547771"], "spl_set_id": ["23c40ef8-6338-46f8-aca9-1aa4f3b2207b"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "4 mL in 1 BOTTLE, DROPPER (50090-2364-1)", "package_ndc": "50090-2364-1", "marketing_start_date": "20190923"}], "brand_name": "Tetracaine Hydrochloride", "product_id": "50090-2364_c7b72c56-5267-471a-8370-55a0f0122e5f", "dosage_form": "SOLUTION", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "50090-2364", "generic_name": "tetracaine hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetracaine Hydrochloride", "active_ingredients": [{"name": "TETRACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA208135", "marketing_category": "NDA", "marketing_start_date": "20161102", "listing_expiration_date": "20261231"}