NDC 17478-097

Cyclopentolate Hydrochloride

Cyclopentolate Hydrochloride

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

Product ID17478-097_1c7ca758-c169-4393-8d6c-2d9a1733291f
NDC17478-097
Product TypeHuman Prescription Drug
Proprietary NameCyclopentolate Hydrochloride
Generic NameCyclopentolate Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1997-01-13
Marketing CategoryANDA / ANDA
Application NumberANDA040165
Labeler NameAkorn
Substance NameCYCLOPENTOLATE HYDROCHLORIDE
Active Ingredient Strength20 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 17478-097-02

1 BOTTLE, DROPPER in 1 CARTON (17478-097-02) > 2 mL in 1 BOTTLE, DROPPER
Marketing Start Date1997-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-097-20 [17478009720]

Cyclopentolate Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA040165
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-01-13
Marketing End Date2011-10-31

NDC 17478-097-12 [17478009712]

Cyclopentolate Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA040165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-01-13

NDC 17478-097-10 [17478009710]

Cyclopentolate Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA040165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-01-13

NDC 17478-097-02 [17478009702]

Cyclopentolate Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA040165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-01-13

Drug Details

Active Ingredients

IngredientStrength
CYCLOPENTOLATE HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:0672f2f5-1f59-4f80-93e3-f3cef09c9bce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298066
  • 1298070
    • UPC Code
  • 0317478097105
  • 0317478100027

    • Medicade Reported Pricing

    17478009702 CYCLOPENTOLATE HCL 2% DROPS

    Pricing Unit: ML | Drug Type:

    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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