NDC 14789-010

Dicyclomine HCl

Dicyclomine Hydrochloride

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

Product ID14789-010_231074f1-f617-4629-9756-0311d49dce46
NDC14789-010
Product TypeHuman Prescription Drug
Proprietary NameDicyclomine HCl
Generic NameDicyclomine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA206468
Labeler NameNexus Pharmaceuticals Inc.
Substance NameDICYCLOMINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 14789-010-02

5 VIAL, SINGLE-DOSE in 1 CARTON (14789-010-02) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14789-010-02 [14789001002]

Dicyclomine HCl INJECTION
Marketing CategoryANDA
Application NumberANDA206468
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-02-18

Drug Details

Active Ingredients

IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:be216fa1-e509-4ae5-a62a-550881d090ae
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 HCl" or generic name "Dicyclomine Hydrochloride"

    NDCBrand NameGeneric Name
    14789-010Dicyclomine HClDicyclomine Hydrochloride
    0143-1227DicyclomineDicyclomine hydrochloride
    0615-0327Dicyclominedicyclomine hydrochloride
    0615-1516DicyclomineDicyclomine Hydrochloride
    10544-597DicyclomineDicyclomine 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.