NDC 21695-883

AK-PENTOLATE

Cyclopentolate Hydrochloride

AK-PENTOLATE 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 ID21695-883_1d97ba11-5b69-4ba3-9310-fa000183de43
NDC21695-883
Product TypeHuman Prescription Drug
Proprietary NameAK-PENTOLATE
Generic NameCyclopentolate Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1997-01-13
Marketing CategoryANDA / ANDA
Application NumberANDA040164
Labeler NameRebel Distributors Corp.
Substance NameCYCLOPENTOLATE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-883-15

15 mL in 1 BOTTLE, DROPPER (21695-883-15)
Marketing Start Date1997-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-883-15 [21695088315]

AK-PENTOLATE SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA040164
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-01-13
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
CYCLOPENTOLATE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:1d97ba11-5b69-4ba3-9310-fa000183de43
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298066
  • 1298352

    • NDC Crossover Matching brand name "AK-PENTOLATE" or generic name "Cyclopentolate Hydrochloride"

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