NDC 52959-168

DICYCLOMINE HYDROCHLORIDE

Dicyclomine Hydrochloride

DICYCLOMINE HYDROCHLORIDE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company Inc.. The primary component is Dicyclomine Hydrochloride.

Product ID52959-168_5fb0acc3-3e30-732e-e053-2a91aa0af3cc
NDC52959-168
Product TypeHuman Prescription Drug
Proprietary NameDICYCLOMINE HYDROCHLORIDE
Generic NameDicyclomine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA040319
Labeler NameH.J. Harkins Company inc.
Substance NameDICYCLOMINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52959-168-00

100 CAPSULE in 1 CONTAINER (52959-168-00)
Marketing Start Date2017-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-168-00 [52959016800]

DICYCLOMINE HYDROCHLORIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA040319
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-168-40 [52959016840]

DICYCLOMINE HYDROCHLORIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA040319
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-168-30 [52959016830]

DICYCLOMINE HYDROCHLORIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA040319
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

NDC 52959-168-12 [52959016812]

DICYCLOMINE HYDROCHLORIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA040319
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:5fb0acc3-3e2f-732e-e053-2a91aa0af3cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991061
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

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

    NDCBrand NameGeneric Name
    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
    68071-3310Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68071-1908Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68071-3035Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68071-3255Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68071-4782Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68083-320DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE
    68151-1161dicyclomine hydrochloridedicyclomine hydrochloride
    68151-2265Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68788-6404Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68788-7059Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68788-6937Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68788-9291Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68788-9525Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68788-9705Dicyclomine HydrochlorideDicyclomine Hydrochloride
    68788-9935Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-0236Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-0327Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-0100Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-0755Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-0858Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-0302Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-1596Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-1732Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70518-1767Dicyclomine HydrochlorideDicyclomine Hydrochloride
    70934-182Dicyclomine HydrochlorideDicyclomine Hydrochloride
    71205-043Dicyclomine HydrochlorideDicyclomine Hydrochloride
    71335-0425Dicyclomine HydrochlorideDicyclomine Hydrochloride
    71335-0588Dicyclomine HydrochlorideDicyclomine Hydrochloride
    71335-0641Dicyclomine HydrochlorideDicyclomine Hydrochloride
    71335-0938Dicyclomine HydrochlorideDicyclomine Hydrochloride
    71335-0471Dicyclomine HydrochlorideDicyclomine Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.