proparacaine hydrochloride

Generic: proparacaine hydrochloride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name proparacaine hydrochloride
Generic Name proparacaine hydrochloride
Labeler micro labs limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

proparacaine hydrochloride 5 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-497
Product ID 42571-497_41be90a9-dfee-6fcc-e063-6394a90a4124
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219294
Listing Expiration 2026-12-31
Marketing Start 2026-02-01

Pharmacologic Class

Classes
local anesthesia [pe] local anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571497
Hyphenated Format 42571-497

Supplemental Identifiers

RxCUI
1191013
UPC
0342571497576
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 ANDA219294 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

42571-497-57 1 BOTTLE in 1 CARTON (42571-497-57) / 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": "41be90a9-dfee-6fcc-e063-6394a90a4124", "openfda": {"upc": ["0342571497576"], "unii": ["U96OL57GOY"], "rxcui": ["1191013"], "spl_set_id": ["df1af0e8-7d9d-4511-9d86-f0c31a5da2c2"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42571-497-57)  / 15 mL in 1 BOTTLE", "package_ndc": "42571-497-57", "marketing_start_date": "20260201"}], "brand_name": "Proparacaine hydrochloride", "product_id": "42571-497_41be90a9-dfee-6fcc-e063-6394a90a4124", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Local Anesthesia [PE]", "Local Anesthetic [EPC]"], "product_ndc": "42571-497", "generic_name": "Proparacaine hydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Proparacaine hydrochloride", "active_ingredients": [{"name": "PROPARACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA219294", "marketing_category": "ANDA", "marketing_start_date": "20260201", "listing_expiration_date": "20261231"}