NDC 21695-218

Dicyclomine

Dicyclomine

Dicyclomine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Dicyclomine Hydrochloride.

Product ID21695-218_1971dce3-875a-43e7-aafc-528600da92b5
NDC21695-218
Product TypeHuman Prescription Drug
Proprietary NameDicyclomine
Generic NameDicyclomine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1997-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA040204
Labeler NameRebel Distributors Corp.
Substance NameDICYCLOMINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-218-60

60 CAPSULE in 1 BOTTLE, PLASTIC (21695-218-60)
Marketing Start Date1997-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-218-30 [21695021830]

Dicyclomine CAPSULE
Marketing CategoryANDA
Application NumberANDA040204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-02-28
Inactivation Date2019-09-24

NDC 21695-218-90 [21695021890]

Dicyclomine CAPSULE
Marketing CategoryANDA
Application NumberANDA040204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-02-28
Inactivation Date2019-09-24

NDC 21695-218-60 [21695021860]

Dicyclomine CAPSULE
Marketing CategoryANDA
Application NumberANDA040204
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-02-28
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:da10031f-9da8-49a2-a019-5ce80c4b7ede
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991061

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

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

    NDCBrand NameGeneric Name
    0143-1227DicyclomineDicyclomine hydrochloride
    0615-0327Dicyclominedicyclomine hydrochloride
    0615-1516DicyclomineDicyclomine Hydrochloride
    10544-597DicyclomineDicyclomine Hydrochloride
    17478-015DicyclomineDicyclomine Hydrochloride
    21695-218DicyclomineDicyclomine
    50090-5454DicyclomineDicyclomine hydrochloride
    52959-221DicyclomineDicyclomine Hydrochloride
    53808-0611DicyclomineDICYCLOMINE HYDROCHLORIDE
    53808-0899DicyclomineDicyclomine Hydrochloride
    55700-933DicyclomineDicyclomine hydrochloride
    67296-1741DicyclomineDicyclomine hydrochloride
    68788-9934DicyclomineDicyclomine Hydrochloride
    70934-518DicyclomineDicyclomine hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.