NDC 0143-9297

Dantrolene

Dantrolene

Dantrolene is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Dantrolene Sodium.

Product ID0143-9297_eafbaffa-64c7-4bee-9ad5-235399687f81
NDC0143-9297
Product TypeHuman Prescription Drug
Proprietary NameDantrolene
Generic NameDantrolene
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-06-19
Marketing CategoryANDA / ANDA
Application NumberANDA204762
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameDANTROLENE SODIUM
Active Ingredient Strength20 mg/1
Pharm ClassesDecreased Striated Muscle Contraction [PE], Decreased Striated Muscle Tone [PE], Skeletal Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0143-9297-01

1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01)
Marketing Start Date2017-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9297-06 [00143929706]

Dantrolene INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-19
Marketing End Date2019-02-01

NDC 0143-9297-01 [00143929701]

Dantrolene INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204762
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-19

Drug Details

Active Ingredients

IngredientStrength
DANTROLENE SODIUM20 mg/1

OpenFDA Data

SPL SET ID:ab0efc75-0598-4f4e-91ad-6195bb2661fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856696
  • 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]

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