NDC 68083-320

DICYCLOMINE HYDROCHLORIDE

Dicyclomine Hydrochloride

DICYCLOMINE HYDROCHLORIDE is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Dicyclomine Hydrochloride.

Product ID68083-320_3b7a6d2b-8d0d-45e3-9778-9a9e010aaf42
NDC68083-320
Product TypeHuman Prescription Drug
Proprietary NameDICYCLOMINE HYDROCHLORIDE
Generic NameDicyclomine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2017-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA210979
Labeler NameGland Pharma Limited
Substance NameDICYCLOMINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-320-10

10 VIAL, SINGLE-DOSE in 1 CARTON (68083-320-10) > 2 mL in 1 VIAL, SINGLE-DOSE (68083-320-01)
Marketing Start Date2017-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-320-01 [68083032001]

DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210979
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-20

NDC 68083-320-10 [68083032010]

DICYCLOMINE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210979
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-20

Drug Details

Active Ingredients

IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:78873936-ebf4-474e-a368-82d3698d5132
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991065

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • 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
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