tetracaine hydrochloride

Generic: tetracaine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetracaine hydrochloride
Generic Name tetracaine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

tetracaine hydrochloride 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-597
Product ID 70069-597_8d8c6ec7-7369-4f34-88bf-e8827fb87ef0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217227
Listing Expiration 2026-12-31
Marketing Start 2024-12-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069597
Hyphenated Format 70069-597

Supplemental Identifiers

RxCUI
1547771
UPC
0370069596012 0370069597019
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 ANDA217227 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-597-01) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-597-01 1 BOTTLE in 1 CARTON (70069-597-01) / 15 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": "8d8c6ec7-7369-4f34-88bf-e8827fb87ef0", "openfda": {"upc": ["0370069596012", "0370069597019"], "unii": ["5NF5D4OPCI"], "rxcui": ["1547771"], "spl_set_id": ["bab63a18-3069-48a1-896e-433725f1dbaf"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-597-01)  / 15 mL in 1 BOTTLE", "package_ndc": "70069-597-01", "marketing_start_date": "20241223"}], "brand_name": "Tetracaine Hydrochloride", "product_id": "70069-597_8d8c6ec7-7369-4f34-88bf-e8827fb87ef0", "dosage_form": "SOLUTION", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "70069-597", "generic_name": "Tetracaine Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetracaine Hydrochloride", "active_ingredients": [{"name": "TETRACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA217227", "marketing_category": "ANDA", "marketing_start_date": "20241223", "listing_expiration_date": "20261231"}