tetracaine hydrochloride

Generic: tetracaine hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetracaine hydrochloride
Generic Name tetracaine hydrochloride
Labeler remedyrepack inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

tetracaine hydrochloride 5 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4183
Product ID 70518-4183_35bf62a6-b5a0-9582-e063-6394a90a1b92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208135
Listing Expiration 2026-12-31
Marketing Start 2024-09-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184183
Hyphenated Format 70518-4183

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
  • 12 BOTTLE, DROPPER in 1 CARTON (70518-4183-0) / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1)
source: ndc

Packages (1)

70518-4183-0 12 BOTTLE, DROPPER in 1 CARTON (70518-4183-0) / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1)

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": "35bf62a6-b5a0-9582-e063-6394a90a1b92", "openfda": {"unii": ["5NF5D4OPCI"], "rxcui": ["1547771"], "spl_set_id": ["01fba5f8-a60a-444c-9abd-299540b8815a"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "12 BOTTLE, DROPPER in 1 CARTON (70518-4183-0)  / 4 mL in 1 BOTTLE, DROPPER (70518-4183-1)", "package_ndc": "70518-4183-0", "marketing_start_date": "20240924"}], "brand_name": "Tetracaine Hydrochloride", "product_id": "70518-4183_35bf62a6-b5a0-9582-e063-6394a90a1b92", "dosage_form": "SOLUTION", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "70518-4183", "generic_name": "tetracaine hydrochloride", "labeler_name": "REMEDYREPACK 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": "20240924", "listing_expiration_date": "20261231"}