NDC 0998-0016

Alcaine

Proparacaine Hydrochloride

Alcaine is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Proparacaine Hydrochloride.

Product ID0998-0016_29e79da7-a158-49c7-8cf6-72c59188c8fd
NDC0998-0016
Product TypeHuman Prescription Drug
Proprietary NameAlcaine
Generic NameProparacaine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1973-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA080027
Labeler NameAlcon Laboratories, Inc.
Substance NamePROPARACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesLocal Anesthesia [PE], Local Anesthetic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0998-0016-15

1 BOTTLE in 1 CARTON (0998-0016-15) > 15 mL in 1 BOTTLE
Marketing Start Date1973-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0998-0016-15 [00998001615]

Alcaine SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA080027
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1973-10-19

Drug Details

Active Ingredients

IngredientStrength
PROPARACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:0c0fa0bf-977d-4539-b8dc-54c187c5b094
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191013
  • 1191026
    • UPC Code
  • 0309980016156

    • Pharmacological Class

    • Local Anesthesia [PE]
    • Local Anesthetic [EPC]

    NDC Crossover Matching brand name "Alcaine" or generic name "Proparacaine Hydrochloride"

    NDCBrand NameGeneric Name
    0998-0016Alcaineproparacaine hydrochloride
    0404-7199Proparacaine HydrochlorideProparacaine Hydrochloride
    13985-611Proparacaine HydrochlorideProparacaine Hydrochloride
    17478-263Proparacaine HydrochlorideProparacaine Hydrochloride
    21695-530Proparacaine HydrochlorideProparacaine Hydrochloride
    24208-730Proparacaine HydrochlorideProparacaine Hydrochloride
    50090-0259Proparacaine HydrochlorideProparacaine Hydrochloride
    50090-1923Proparacaine HydrochlorideProparacaine Hydrochloride
    50090-1931Proparacaine HydrochlorideProparacaine Hydrochloride
    52959-705Proparacaine HydrochlorideProparacaine Hydrochloride
    61314-016Proparacaine HydrochlorideProparacaine Hydrochloride
    68071-1332Proparacaine HydrochlorideProparacaine Hydrochloride
    68071-4368Proparacaine HydrochlorideProparacaine Hydrochloride
    68071-4701Proparacaine HydrochlorideProparacaine Hydrochloride
    68071-5139proparacaine hydrochlorideproparacaine hydrochloride
    68788-0736Proparacaine HydrochlorideProparacaine Hydrochloride
    70518-2056Proparacaine HydrochlorideProparacaine Hydrochloride
    70518-3408Proparacaine HydrochlorideProparacaine Hydrochloride

    Trademark Results [Alcaine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ALCAINE
    ALCAINE
    76218842 2614575 Live/Registered
    ALCON RESEARCH, LTD.
    2001-03-02
    ALCAINE
    ALCAINE
    73198884 1130668 Dead/Cancelled
    ALCON LABORATORIES, INC.
    1978-12-26
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