NDC 17478-015

Dicyclomine

Dicyclomine Hydrochloride

Dicyclomine is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Dicyclomine Hydrochloride.

Product ID17478-015_055ab643-78ca-4951-80b2-8fc80c6dcdc5
NDC17478-015
Product TypeHuman Prescription Drug
Proprietary NameDicyclomine
Generic NameDicyclomine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2018-05-04
Marketing CategoryANDA / ANDA
Application NumberANDA207084
Labeler NameAkorn
Substance NameDICYCLOMINE HYDROCHLORIDE
Active Ingredient Strength20 mg/2mL
Pharm ClassesAnticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 17478-015-02

5 AMPULE in 1 CARTON (17478-015-02) > 2 mL in 1 AMPULE
Marketing Start Date2018-05-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-015-02 [17478001502]

Dicyclomine INJECTION
Marketing CategoryANDA
Application NumberANDA207084
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-04

Drug Details

Active Ingredients

IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/2mL

OpenFDA Data

SPL SET ID:8e1592ba-03cd-4831-bd7c-4c0eeaa06fd1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991065
    • UPC Code
  • 0317478015024

    • Pharmacological Class

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