NDC 27505-003

Revonto

Dantrolene Sodium

Revonto is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Us Worldmeds, Llc. The primary component is Dantrolene Sodium.

Product ID27505-003_6040962a-5507-4ca7-aa11-a98e68fab263
NDC27505-003
Product TypeHuman Prescription Drug
Proprietary NameRevonto
Generic NameDantrolene Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-06-04
Marketing CategoryANDA / ANDA
Application NumberANDA078378
Labeler NameUS WorldMeds, LLC
Substance NameDANTROLENE SODIUM
Active Ingredient Strength20 mg/60mL
Pharm ClassesDecreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 27505-003-67

6 VIAL, GLASS in 1 CARTON (27505-003-67) > 60 mL in 1 VIAL, GLASS
Marketing Start Date2012-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27505-003-67 [27505000367]

Revonto INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA078378
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-06-04

NDC 27505-003-68 [27505000368]

Revonto INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA078378
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-06-04
Marketing End Date2017-03-31

Drug Details

Active Ingredients

IngredientStrength
DANTROLENE SODIUM20 mg/60mL

OpenFDA Data

SPL SET ID:78801254-73a0-44ca-9222-7b3581af82d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856696
  • 1012465

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    27505-003Revontodantrolene sodium
    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
    42367-540RYANODEXdantrolene sodium

    Trademark Results [Revonto]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    REVONTO
    REVONTO
    77880100 3871489 Live/Registered
    US WorldMeds, LLC
    2009-11-24
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