NDC 50090-1635

Epinastine Hydrochloride

Epinastine Hydrochloride

Epinastine Hydrochloride is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Epinastine Hydrochloride.

Product ID50090-1635_3592bbdc-acc8-40a6-b284-4fceca8ca464
NDC50090-1635
Product TypeHuman Prescription Drug
Proprietary NameEpinastine Hydrochloride
Generic NameEpinastine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2013-11-05
Marketing CategoryANDA / ANDA
Application NumberANDA090870
Labeler NameA-S Medication Solutions
Substance NameEPINASTINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesAdrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50090-1635-0

1 BOTTLE, DROPPER in 1 CARTON (50090-1635-0) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2015-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-1635-0 [50090163500]

Epinastine Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA090870
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-15
Marketing End Date2018-03-31

Drug Details

Active Ingredients

IngredientStrength
EPINASTINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:6099119a-0cb4-4c63-a893-861a930686fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860654

    • Pharmacological Class

    • Adrenergic Agonists [MoA]
    • Adrenergic Receptor Agonist [EPC]
    • Decreased Histamine Release [PE]
    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Inhibitor [EPC]

    NDC Crossover Matching brand name "Epinastine Hydrochloride" or generic name "Epinastine Hydrochloride"

    NDCBrand NameGeneric Name
    50090-1635Epinastine HydrochlorideEpinastine Hydrochloride
    51991-836Epinastine HydrochlorideEpinastine Hydrochloride
    60505-0584Epinastine HydrochlorideEpinastine Hydrochloride
    62756-329EPINASTINE HYDROCHLORIDEEPINASTINE HYDROCHLORIDE
    70069-008EPINASTINE HYDROCHLORIDEEPINASTINE HYDROCHLORIDE
    0023-9201ELESTATepinastine hydrochloride
    17478-911EpinastineEpinastine Hydrochloride
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