NDC 70069-121

Tropicamide

Tropicamide

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

Product ID70069-121_277e0514-f888-4f0e-a3dc-386e9d913c00
NDC70069-121
Product TypeHuman Prescription Drug
Proprietary NameTropicamide
Generic NameTropicamide
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-12-12
Marketing CategoryANDA / ANDA
Application NumberANDA207524
Labeler NameSomerset Therapeutics, LLC
Substance NameTROPICAMIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70069-121-01

1 BOTTLE in 1 CARTON (70069-121-01) > 15 mL in 1 BOTTLE
Marketing Start Date2019-12-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-121-01 [70069012101]

Tropicamide SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA207524
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-12

Drug Details

Active Ingredients

IngredientStrength
TROPICAMIDE10 mg/mL

OpenFDA Data

SPL SET ID:378b5fe2-4b5d-4c87-a7d6-fd0caa6402af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314238
  • UPC Code
  • 0370069121016
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    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

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