NDC 17478-101

Tropicamide

Tropicamide

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

Product ID17478-101_42cf2e28-f9df-4dd6-88f9-ecad8522079c
NDC17478-101
Product TypeHuman Prescription Drug
Proprietary NameTropicamide
Generic NameTropicamide
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2000-09-29
Marketing CategoryANDA / ANDA
Application NumberANDA040314
Labeler NameAkorn, Inc.
Substance NameTROPICAMIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 17478-101-12

1 BOTTLE, DROPPER in 1 CARTON (17478-101-12) > 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date2000-09-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-101-12 [17478010112]

Tropicamide SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA040314
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-09-29

Drug Details

Active Ingredients

IngredientStrength
TROPICAMIDE5 mg/mL

OpenFDA Data

SPL SET ID:329a3382-3718-4311-890f-97c6b7e0077c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313521
  • 314238
  • UPC Code
  • 0317478101123
  • 0317478102120
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    Medicade Reported Pricing

    17478010112 TROPICAMIDE 0.5% EYE DROPS

    Pricing Unit: ML | Drug Type:

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

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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.