NDC 50090-4553

Bentyl

Dicyclomine Hydrochloride

Bentyl is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Dicyclomine Hydrochloride.

Product ID50090-4553_019baede-7e92-4877-ac1a-f4fc35661651
NDC50090-4553
Product TypeHuman Prescription Drug
Proprietary NameBentyl
Generic NameDicyclomine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date1952-08-13
Marketing CategoryNDA / NDA
Application NumberNDA008370
Labeler NameA-S Medication Solutions
Substance NameDICYCLOMINE HYDROCHLORIDE
Active Ingredient Strength20 mg/2mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50090-4553-0

2 mL in 1 AMPULE (50090-4553-0)
Marketing Start Date2019-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-4553-0 [50090455300]

Bentyl INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA008370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/2mL

OpenFDA Data

SPL SET ID:3e078249-7555-41ff-93f6-0b1260651aa1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991065
  • 991069

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    58914-080BentylBentyl
    58914-013BentylBentyl
    50090-4553BentylBentyl
    0143-1227DicyclomineDicyclomine hydrochloride
    0615-0327Dicyclominedicyclomine hydrochloride
    0615-1516DicyclomineDicyclomine Hydrochloride
    10544-597DicyclomineDicyclomine Hydrochloride
    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

    Trademark Results [Bentyl]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BENTYL
    BENTYL
    72059832 0681724 Live/Registered
    Wm. S. Merrell Company, The
    1958-09-30
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.