NDC 10544-597

Dicyclomine

Dicyclomine Hydrochloride

Dicyclomine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Blenheim Pharmacal, Inc.. The primary component is Dicyclomine Hydrochloride.

Product ID10544-597_fbeea6f8-f60a-494c-8bdf-093e48be509e
NDC10544-597
Product TypeHuman Prescription Drug
Proprietary NameDicyclomine
Generic NameDicyclomine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA040161
Labeler NameBlenheim Pharmacal, Inc.
Substance NameDICYCLOMINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10544-597-30

30 TABLET in 1 BOTTLE (10544-597-30)
Marketing Start Date2011-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10544-597-30 [10544059730]

Dicyclomine TABLET
Marketing CategoryANDA
Application NumberANDA040161
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-04-01
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:d70e3238-cb91-44eb-8598-f8713b89be97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991086
    • UPC Code
  • 0310544597301

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Dicyclomine" or generic name "Dicyclomine Hydrochloride"

    NDCBrand NameGeneric Name
    0143-1227DicyclomineDicyclomine hydrochloride
    0615-0327Dicyclominedicyclomine hydrochloride
    0615-1516DicyclomineDicyclomine Hydrochloride
    10544-597DicyclomineDicyclomine Hydrochloride
    68788-9934DicyclomineDicyclomine
    17478-015DicyclomineDicyclomine
    21695-218DicyclomineDicyclomine
    52959-221DicyclomineDicyclomine
    53808-0611DicyclomineDicyclomine
    53808-0899DicyclomineDicyclomine
    67296-1741DicyclomineDicyclomine
    70934-518DicyclomineDicyclomine
    14789-010Dicyclomine HClDicyclomine Hydrochloride
    0054-0622Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0143-3126Dicyclomine hydrochlorideDicyclomine hydrochloride
    0378-1610Dicyclomine Hydrochloridedicyclomine hydrochloride
    0378-1620Dicyclomine Hydrochloridedicyclomine hydrochloride
    0440-7384Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0517-1980Dicyclomine hydrochlorideDicyclomine hydrochloride
    0527-0586Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0527-1282Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0591-0794Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0591-0795Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0603-1161dicyclomine hydrochloridedicyclomine hydrochloride
    0615-7754Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0615-7755Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0641-6173Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0904-6969Dicyclomine hydrochlorideDicyclomine hydrochloride
    0904-6987Dicyclomine HydrochlorideDicyclomine Hydrochloride
    0904-6988Dicyclomine HydrochlorideDicyclomine Hydrochloride
    10135-520Dicyclomine HydrochlorideDicyclomine Hydrochloride
    10544-560Dicyclomine HydrochlorideDicyclomine Hydrochloride
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