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 68071-5139
Product ID 68071-5139_2abe0121-d9c6-92c1-e063-6294a90afa54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080027
Listing Expiration 2026-12-31
Marketing Start 1973-10-19

Pharmacologic Class

Classes
local anesthesia [pe] local anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680715139
Hyphenated Format 68071-5139

Supplemental Identifiers

RxCUI
1191013
UPC
0368071513950
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 ANDA080027 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (68071-5139-5)
source: ndc

Packages (1)

68071-5139-5 15 mL in 1 BOTTLE (68071-5139-5)

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": "2abe0121-d9c6-92c1-e063-6294a90afa54", "openfda": {"upc": ["0368071513950"], "unii": ["U96OL57GOY"], "rxcui": ["1191013"], "spl_set_id": ["9a67a989-ec6b-4a26-e053-2a95a90a826d"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (68071-5139-5)", "package_ndc": "68071-5139-5", "marketing_start_date": "20191223"}], "brand_name": "proparacaine hydrochloride", "product_id": "68071-5139_2abe0121-d9c6-92c1-e063-6294a90afa54", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Local Anesthesia [PE]", "Local Anesthetic [EPC]"], "product_ndc": "68071-5139", "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": "ANDA080027", "marketing_category": "ANDA", "marketing_start_date": "19731019", "listing_expiration_date": "20261231"}