NDC 55045-3598

EpiPen Jr

Epinephrine

EpiPen Jr is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Epinephrine.

Product ID55045-3598_e49b84de-9d18-439a-8c09-fdb24ba0179a
NDC55045-3598
Product TypeHuman Prescription Drug
Proprietary NameEpiPen Jr
Generic NameEpinephrine
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date1987-12-22
Marketing CategoryNDA / NDA
Application NumberNDA019430
Labeler NameDispensing Solutions, Inc.
Substance NameEPINEPHRINE
Active Ingredient Strength0 mg/.3mL
Pharm ClassesAdrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 55045-3598-1

2 CONTAINER in 1 CARTON (55045-3598-1) > 1 SYRINGE, GLASS in 1 CONTAINER > .3 mL in 1 SYRINGE, GLASS
Marketing Start Date1987-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55045-3598-1 [55045359801]

EpiPen Jr INJECTION
Marketing CategoryNDA
Application NumberNDA019430
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1987-12-22
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
EPINEPHRINE.15 mg/.3mL

OpenFDA Data

SPL SET ID:6d0fc046-a2d4-4bca-b8f2-f24161a1bf73
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 727316
  • 727386
  • Pharmacological Class

    • Adrenergic alpha-Agonists [MoA]
    • Adrenergic beta-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • beta-Adrenergic Agonist [EPC]
    • Catecholamine [EPC]
    • Catecholamines [CS]

    NDC Crossover Matching brand name "EpiPen Jr" or generic name "Epinephrine"

    NDCBrand NameGeneric Name
    49502-501EPIPEN JREPIPEN JR
    50090-1243EPIPEN JREPIPEN JR
    55045-3598EpiPen JrEpiPen Jr
    64725-0501EPIPEN JREPIPEN JR
    0220-0076AdrenalinumEPINEPHRINE
    0220-0078AdrenalinumEPINEPHRINE
    0093-5985EpinephrineEpinephrine
    0093-5986EpinephrineEpinephrine
    0115-1694epinephrineepinephrine
    0115-1695epinephrineepinephrine
    0404-9856EpinephrineEpinephrine
    0404-9857EPINEPHRINEEPINEPHRINE
    0409-4921EpinephrineEPINEPHRINE
    0409-4933EPINEPHRINEepinephrine
    0409-7241EPINEPHRINEepinephrine
    0517-1130EpinephrineEpinephrine
    0517-1171epinephrineepinephrine
    0781-3442SYMJEPIEpinephrine
    0781-3448SYMJEPIEpinephrine

    Trademark Results [EpiPen Jr]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EPIPEN JR
    EPIPEN JR
    85037357 3969162 Live/Registered
    Mylan Inc.
    2010-05-13

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.