NDC 0115-4422

Dantrolene Sodium

Dantrolene Sodium

Dantrolene Sodium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Dantrolene Sodium.

Product ID0115-4422_136adc42-ef12-4bc7-849c-89cca8629012
NDC0115-4422
Product TypeHuman Prescription Drug
Proprietary NameDantrolene Sodium
Generic NameDantrolene Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2005-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA076856
Labeler NameImpax Generics
Substance NameDANTROLENE SODIUM
Active Ingredient Strength50 mg/1
Pharm ClassesDecreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0115-4422-01

100 CAPSULE in 1 BOTTLE (0115-4422-01)
Marketing Start Date2005-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-4422-03 [00115442203]

Dantrolene Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA076856
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-03-01

NDC 0115-4422-01 [00115442201]

Dantrolene Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA076856
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-03-01

NDC 0115-4422-02 [00115442202]

Dantrolene Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA076856
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-03-01

Drug Details

Active Ingredients

IngredientStrength
DANTROLENE SODIUM50 mg/1

OpenFDA Data

SPL SET ID:c3c45b27-f786-456e-95d6-2e38ef36190a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856652
  • 856660
  • 856656
    • UPC Code
  • 0301154411019
  • 0301154433011
  • 0301154422015

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68151-1520Dantrolene SodiumDantrolene Sodium
    42023-123Dantriumdantrolene sodium
    42023-124Dantriumdantrolene sodium
    42023-125Dantriumdantrolene sodium
    27505-003Revontodantrolene sodium
    42367-540RYANODEXdantrolene sodium
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.