NDC 0065-0396

Cyclogyl

Cyclopentolate Hydrochloride

Cyclogyl 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.

Product ID0065-0396_0efa8dfd-801e-490e-85a1-e49b7095adba
NDC0065-0396
Product TypeHuman Prescription Drug
Proprietary NameCyclogyl
Generic NameCyclopentolate Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1975-10-15
Marketing CategoryANDA / ANDA
Application NumberANDA084110
Labeler NameAlcon Laboratories, Inc.
Substance NameCYCLOPENTOLATE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0065-0396-02

1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-02) > 2 mL in 1 BOTTLE, PLASTIC
Marketing Start Date1975-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-0396-05 [00065039605]

Cyclogyl SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA084110
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1975-10-15

NDC 0065-0396-15 [00065039615]

Cyclogyl SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA084110
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1975-10-15
Marketing End Date2019-07-31

NDC 0065-0396-02 [00065039602]

Cyclogyl SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA084110
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1975-10-15

Drug Details

Active Ingredients

IngredientStrength
CYCLOPENTOLATE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:1d008c76-7210-4ace-90fa-7cd22762e12e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298356
  • 1298066
  • 1298070
  • 1298072
  • 1298364
  • 1298366

    • NDC Crossover Matching brand name "Cyclogyl" or generic name "Cyclopentolate Hydrochloride"

    NDCBrand NameGeneric Name
    0065-0395Cyclogylcyclopentolate hydrochloride
    0065-0396Cyclogylcyclopentolate hydrochloride
    0065-0397Cyclogylcyclopentolate hydrochloride
    21695-883AK-PENTOLATECyclopentolate Hydrochloride
    17478-096CyclopentolateCyclopentolate Hydrochloride
    17478-097Cyclopentolate HydrochlorideCyclopentolate Hydrochloride
    17478-100Cyclopentolate HydrochlorideCyclopentolate Hydrochloride
    24208-735Cyclopentolate HydrochlorideCyclopentolate Hydrochloride
    42254-013Cyclopentolate HydrochlorideCyclopentolate Hydrochloride
    50090-3234Cyclopentolate HydrochlorideCyclopentolate Hydrochloride
    50090-3874Cyclopentolate HydrochlorideCyclopentolate Hydrochloride
    61314-396Cyclopentolate HydrochlorideCyclopentolate Hydrochloride

    Trademark Results [Cyclogyl]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYCLOGYL
    CYCLOGYL
    71626540 0572620 Live/Registered
    SCHIEFFELIN & CO.
    1952-03-15
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.