NDC 0065-0359

Cyclomydril

Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride

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

Product ID0065-0359_2eecefd2-b17c-4659-8393-cb8d34c48337
NDC0065-0359
Product TypeHuman Prescription Drug
Proprietary NameCyclomydril
Generic NameCyclopentolate Hydrochloride And Phenylephrine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1958-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA084300
Labeler NameAlcon Laboratories, Inc.
Substance NameCYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength2 mg/mL; mg/mL
Pharm Classesalpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0065-0359-02

2 mL in 1 BOTTLE, PLASTIC (0065-0359-02)
Marketing Start Date1958-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0359-05 [00065035905]

Cyclomydril SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA084300
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1958-06-30

NDC 0065-0359-02 [00065035902]

Cyclomydril SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA084300
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1958-06-30

Drug Details

Active Ingredients

IngredientStrength
CYCLOPENTOLATE HYDROCHLORIDE2 mg/mL

OpenFDA Data

SPL SET ID:8268b70f-3f10-48dd-bb24-baaeb27a1325
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298360
  • 1298068
    • UPC Code
  • 0300650359054

    • Pharmacological Class

    • alpha-1 Adrenergic Agonist [EPC]
    • Adrenergic alpha1-Agonists [MoA]

    Trademark Results [Cyclomydril]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYCLOMYDRIL
    CYCLOMYDRIL
    72066934 0685471 Live/Registered
    SCHIEFFELIN & CO.
    1959-02-02
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