alcaine

Generic: proparacaine hydrochloride

Labeler: alcon laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alcaine
Generic Name proparacaine hydrochloride
Labeler alcon laboratories, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

proparacaine hydrochloride 5 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0998-0016
Product ID 0998-0016_5468200d-d85e-4e90-928b-84a91e05185b
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 09980016
Hyphenated Format 0998-0016

Supplemental Identifiers

RxCUI
1191013 1191026
UPC
0309980016156
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 alcaine (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
  • 1 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

0998-0016-15 1 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLE

Ingredients (1)

proparacaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Alcaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "5468200d-d85e-4e90-928b-84a91e05185b", "openfda": {"upc": ["0309980016156"], "unii": ["U96OL57GOY"], "rxcui": ["1191013", "1191026"], "spl_set_id": ["0c0fa0bf-977d-4539-b8dc-54c187c5b094"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0998-0016-15)  / 15 mL in 1 BOTTLE", "package_ndc": "0998-0016-15", "marketing_start_date": "19731019"}], "brand_name": "Alcaine", "product_id": "0998-0016_5468200d-d85e-4e90-928b-84a91e05185b", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Local Anesthesia [PE]", "Local Anesthetic [EPC]"], "product_ndc": "0998-0016", "generic_name": "proparacaine hydrochloride", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alcaine", "active_ingredients": [{"name": "PROPARACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA080027", "marketing_category": "ANDA", "marketing_start_date": "19731019", "listing_expiration_date": "20261231"}