NDC 42254-013

Cyclopentolate Hydrochloride

Cyclopentolate Hydrochloride

Cyclopentolate Hydrochloride is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Cyclopentolate Hydrochloride.

Product ID42254-013_4d4131f8-79d0-40a4-87e8-667fd2db8d7a
NDC42254-013
Product TypeHuman Prescription Drug
Proprietary NameCyclopentolate Hydrochloride
Generic NameCyclopentolate Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1994-04-29
Marketing CategoryANDA / ANDA
Application NumberANDA040075
Labeler NameRebel Distributors Corp
Substance NameCYCLOPENTOLATE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 42254-013-15

1 BOTTLE, DROPPER in 1 CARTON (42254-013-15) > 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date1994-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42254-013-15 [42254001315]

Cyclopentolate Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA040075
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-04-29
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
CYCLOPENTOLATE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:4d4131f8-79d0-40a4-87e8-667fd2db8d7a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298066

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

    NDCBrand NameGeneric Name
    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
    21695-883AK-PENTOLATECyclopentolate Hydrochloride
    0065-0395Cyclogylcyclopentolate hydrochloride
    0065-0396Cyclogylcyclopentolate hydrochloride
    0065-0397Cyclogylcyclopentolate hydrochloride
    17478-096CyclopentolateCyclopentolate Hydrochloride
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