tetracaine hydrochloride

Generic: tetracaine hydrochloride

Labeler: alcon laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetracaine hydrochloride
Generic Name tetracaine hydrochloride
Labeler alcon laboratories, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

tetracaine hydrochloride 5 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0741
Product ID 0065-0741_e5c0f202-3d32-4b47-8d45-e1d031ff7ce9
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 00650741
Hyphenated Format 0065-0741

Supplemental Identifiers

RxCUI
1547771
UPC
0300650741149
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 NDA208135 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (0065-0741-14) / 1 BOTTLE, DROPPER in 1 BLISTER PACK / 4 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

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

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": "e5c0f202-3d32-4b47-8d45-e1d031ff7ce9", "openfda": {"upc": ["0300650741149"], "unii": ["5NF5D4OPCI"], "rxcui": ["1547771"], "spl_set_id": ["5c7b1de4-9f55-1d0e-ef6d-b0ba2cbaba79"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (0065-0741-14)  / 1 BOTTLE, DROPPER in 1 BLISTER PACK / 4 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-0741-14", "marketing_start_date": "20161102"}], "brand_name": "Tetracaine Hydrochloride", "product_id": "0065-0741_e5c0f202-3d32-4b47-8d45-e1d031ff7ce9", "dosage_form": "SOLUTION", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "0065-0741", "generic_name": "tetracaine hydrochloride", "labeler_name": "Alcon Laboratories, Inc.", "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"}