proparacaine hydrochloride

Generic: proparacaine hydrochloride

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

Drug Facts

Product Profile

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

proparacaine hydrochloride 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-601
Product ID 70069-601_abb9ea27-1536-41b3-b84e-839796fdf710
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215816
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

Classes
local anesthesia [pe] local anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069601
Hyphenated Format 70069-601

Supplemental Identifiers

RxCUI
1191013
UPC
0370069601013
UNII
U96OL57GOY

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 proparacaine hydrochloride (source: ndc)
Generic Name proparacaine hydrochloride (source: ndc)
Application Number ANDA215816 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-601-01) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-601-01 1 BOTTLE in 1 CARTON (70069-601-01) / 15 mL in 1 BOTTLE

Ingredients (1)

proparacaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Proparacaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "abb9ea27-1536-41b3-b84e-839796fdf710", "openfda": {"upc": ["0370069601013"], "unii": ["U96OL57GOY"], "rxcui": ["1191013"], "spl_set_id": ["968a6e4e-814f-41f8-ae22-aa5a82179a6c"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-601-01)  / 15 mL in 1 BOTTLE", "package_ndc": "70069-601-01", "marketing_start_date": "20241010"}], "brand_name": "Proparacaine Hydrochloride", "product_id": "70069-601_abb9ea27-1536-41b3-b84e-839796fdf710", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Local Anesthesia [PE]", "Local Anesthetic [EPC]"], "product_ndc": "70069-601", "generic_name": "Proparacaine Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Proparacaine Hydrochloride", "active_ingredients": [{"name": "PROPARACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA215816", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}