tetracaine hydrochloride

Generic: tetracaine hydrochloride

Labeler: bausch & lomb americas inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tetracaine hydrochloride
Generic Name tetracaine hydrochloride
Labeler bausch & lomb americas inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tetracaine hydrochloride 5 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-920
Product ID 82260-920_4a468703-7613-0c8b-e063-6294a90a2f6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA210821
Listing Expiration 2027-12-31
Marketing Start 2022-09-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260920
Hyphenated Format 82260-920

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, DROPPER in 1 CARTON (82260-920-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-920-15) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

82260-920-05 1 BOTTLE, DROPPER in 1 CARTON (82260-920-05) / 5 mL in 1 BOTTLE, DROPPER 82260-920-15 1 BOTTLE, DROPPER in 1 CARTON (82260-920-15) / 15 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": "4a468703-7613-0c8b-e063-6294a90a2f6e", "openfda": {"unii": ["5NF5D4OPCI"], "rxcui": ["1547771"], "spl_set_id": ["f12d5944-0d6c-43ff-89fd-e0b5669e9b4a"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-920-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-920-05", "marketing_start_date": "20220921"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-920-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-920-15", "marketing_start_date": "20220921"}], "brand_name": "Tetracaine Hydrochloride", "product_id": "82260-920_4a468703-7613-0c8b-e063-6294a90a2f6e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "82260-920", "generic_name": "Tetracaine Hydrochloride", "labeler_name": "Bausch & Lomb Americas Inc.", "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 AUTHORIZED GENERIC", "marketing_start_date": "20220921", "listing_expiration_date": "20271231"}