NDC 43063-045

Dicyclomine Hydrochloride

Dicyclomine Hydrochloride

Dicyclomine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Dicyclomine Hyd.

Product ID43063-045_808969fc-5f43-a27f-e053-2a91aa0a6c75
NDC43063-045
Product TypeHuman Prescription Drug
Proprietary NameDicyclomine Hydrochloride
Generic NameDicyclomine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1986-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA085223
Labeler NamePD-Rx Pharmaceuticals, In
Substance NameDICYCLOMINE HYD
Active Ingredient Strength20 mg/1
Pharm ClassesAnticholinergic
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-045-04

4 TABLET in 1 BOTTLE, PLASTIC (43063-045-04)
Marketing Start Date2008-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-045-04 [43063004504]

Dicyclomine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA085223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-12-22

NDC 43063-045-60 [43063004560]

Dicyclomine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA085223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-14

NDC 43063-045-30 [43063004530]

Dicyclomine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA085223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-07

NDC 43063-045-20 [43063004520]

Dicyclomine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA085223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-17

NDC 43063-045-06 [43063004506]

Dicyclomine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA085223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-17

Drug Details

Active Ingredients

IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:da0e1f63-cb90-4c2a-908f-7d81e672be10
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991086
  • UPC Code
  • 0343063045305
  • 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.