proparacaine hydrochloride

Generic: proparacaine hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name proparacaine hydrochloride
Generic Name proparacaine hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

proparacaine hydrochloride 5 mg/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4368
Product ID 68071-4368_1a555cda-0c40-ba30-e063-6394a90a3525
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040074
Listing Expiration 2026-12-31
Marketing Start 1995-09-29

Pharmacologic Class

Classes
local anesthesia [pe] local anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680714368
Hyphenated Format 68071-4368

Supplemental Identifiers

RxCUI
1191013
UPC
0368071436853
UNII
U96OL57GOY

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 ANDA040074 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 15 mL in 1 BOX (68071-4368-5)
source: ndc

Packages (1)

68071-4368-5 15 mL in 1 BOX (68071-4368-5)

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": "1a555cda-0c40-ba30-e063-6394a90a3525", "openfda": {"upc": ["0368071436853"], "unii": ["U96OL57GOY"], "rxcui": ["1191013"], "spl_set_id": ["68a84d3f-a8f8-13ee-e053-2991aa0a7592"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOX (68071-4368-5)", "package_ndc": "68071-4368-5", "marketing_start_date": "20180330"}], "brand_name": "Proparacaine Hydrochloride", "product_id": "68071-4368_1a555cda-0c40-ba30-e063-6394a90a3525", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Local Anesthesia [PE]", "Local Anesthetic [EPC]"], "product_ndc": "68071-4368", "generic_name": "Proparacaine Hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Proparacaine Hydrochloride", "active_ingredients": [{"name": "PROPARACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA040074", "marketing_category": "ANDA", "marketing_start_date": "19950929", "listing_expiration_date": "20261231"}