NDC 42023-124

Dantrium

Dantrolene Sodium

Dantrium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Dantrolene Sodium.

Product ID42023-124_9325c6fb-9c91-40dd-9364-067dd6553ba0
NDC42023-124
Product TypeHuman Prescription Drug
Proprietary NameDantrium
Generic NameDantrolene Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-08-01
Marketing CategoryNDA / NDA
Application NumberNDA017443
Labeler NamePar Pharmaceutical, Inc.
Substance NameDANTROLENE SODIUM
Active Ingredient Strength25 mg/1
Pharm ClassesDecreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42023-124-01

100 CAPSULE in 1 BOTTLE (42023-124-01)
Marketing Start Date2008-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42023-124-01 [42023012401]

Dantrium CAPSULE
Marketing CategoryNDA
Application NumberNDA017443
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-08-01

Drug Details

Active Ingredients

IngredientStrength
DANTROLENE SODIUM25 mg/1

OpenFDA Data

SPL SET ID:57b4eec1-49e1-432c-95ae-0fe36e32d64b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856658
  • 856652
  • 856654
  • 856660
  • 856656
  • 856662

    • Pharmacological Class

    • Decreased Striated Muscle Contraction [PE]
    • Decreased Striated Muscle Tone [PE]
    • Skeletal Muscle Relaxant [EPC]
    • Decreased Striated Muscle Contraction [PE]
    • Decreased Striated Muscle Tone [PE]
    • Skeletal Muscle Relaxant [EPC]

    NDC Crossover Matching brand name "Dantrium" or generic name "Dantrolene Sodium"

    NDCBrand NameGeneric Name
    42023-123Dantriumdantrolene sodium
    42023-124Dantriumdantrolene sodium
    42023-125Dantriumdantrolene sodium
    0115-4411Dantrolene SodiumDantrolene Sodium
    0115-4422Dantrolene SodiumDantrolene Sodium
    0115-4433Dantrolene SodiumDantrolene Sodium
    0527-3219Dantrolene Sodiumdantrolene sodium
    0527-3220Dantrolene Sodiumdantrolene sodium
    0527-3221Dantrolene Sodiumdantrolene sodium
    0904-7211Dantrolene SodiumDantrolene Sodium
    42023-144dantrolene sodiumdantrolene sodium
    49884-362dantrolene sodiumdantrolene sodium
    49884-363dantrolene sodiumdantrolene sodium
    49884-364dantrolene sodiumdantrolene sodium
    50268-217Dantrolene SodiumDantrolene Sodium
    55154-7140Dantrolene SodiumDantrolene Sodium
    63629-2168dantrolene sodiumdantrolene sodium
    63629-2169dantrolene sodiumdantrolene sodium
    63629-2170dantrolene sodiumdantrolene sodium
    64850-840Dantrolene Sodiumdantrolene sodium
    64850-841Dantrolene Sodiumdantrolene sodium
    64850-842Dantrolene Sodiumdantrolene sodium
    68084-300Dantrolene SodiumDantrolene Sodium
    27505-003Revontodantrolene sodium
    42367-540RYANODEXdantrolene sodium

    Trademark Results [Dantrium]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DANTRIUM
    DANTRIUM
    85892501 4432295 Live/Registered
    PAR PHARMACEUTICAL, INC.
    2013-04-02
    DANTRIUM
    DANTRIUM
    73418728 1277831 Live/Registered
    Eaton Laboratories, Inc.
    1983-03-24
    DANTRIUM
    DANTRIUM
    72387314 0937430 Live/Registered
    NORWICH PHARMACAL COMPANY, THE
    1971-03-24
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.