NDC 61314-354

Tropicamide

Tropicamide

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

Product ID61314-354_20cc3da1-82ed-4aa9-ada2-03166a1fe9db
NDC61314-354
Product TypeHuman Prescription Drug
Proprietary NameTropicamide
Generic NameTropicamide
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2000-06-09
Marketing CategoryANDA / ANDA
Application NumberANDA084305
Labeler NameSandoz Inc
Substance NameTROPICAMIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61314-354-01

1 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) > 15 mL in 1 BOTTLE, PLASTIC
Marketing Start Date2000-06-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61314-354-01 [61314035401]

Tropicamide SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA084305
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2000-06-09

Drug Details

Active Ingredients

IngredientStrength
TROPICAMIDE5 mg/mL

OpenFDA Data

SPL SET ID:521592d1-53a1-4314-8b3f-d808f3bccfcd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313521
  • 314238
  • UPC Code
  • 0361314354013
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    Medicade Reported Pricing

    61314035401 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

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