NDC 0998-0355

Mydriacyl

Tropicamide

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

Product ID0998-0355_0061a54d-79b7-48be-b889-b42de0624e33
NDC0998-0355
Product TypeHuman Prescription Drug
Proprietary NameMydriacyl
Generic NameTropicamide
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1959-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA084306
Labeler NameAlcon Laboratories, Inc.
Substance NameTROPICAMIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0998-0355-15

1 BOTTLE in 1 CARTON (0998-0355-15) > 15 mL in 1 BOTTLE
Marketing Start Date1959-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0998-0355-15 [00998035515]

Mydriacyl SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA084306
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1959-04-01

Drug Details

Active Ingredients

IngredientStrength
TROPICAMIDE10 mg/mL

OpenFDA Data

SPL SET ID:0d4f4a2e-eb00-4c65-b3fa-baf5738d468d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 208660
  • 314238
  • UPC Code
  • 0309980355156
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Mydriacyl" or generic name "Tropicamide"

    NDCBrand NameGeneric Name
    0065-0355Mydriacyltropicamide
    0998-0355Mydriacyltropicamide
    0404-7192TropicamideTropicamide
    17478-101TropicamideTropicamide
    17478-102TropicamideTropicamide
    24208-585TropicamideTropicamide
    24208-590TropicamideTropicamide
    61314-354TropicamideTropicamide
    61314-355TropicamideTropicamide
    68071-4004TropicamideTropicamide
    70069-121TropicamideTropicamide
    70518-0744TropicamideTropicamide
    70518-2759TropicamideTropicamide

    Trademark Results [Mydriacyl]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYDRIACYL
    MYDRIACYL
    72096172 0708344 Live/Registered
    ALCON LABORATORIES, INC.
    1960-05-02

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