NDC 51991-836

Epinastine Hydrochloride

Epinastine Hydrochloride

Epinastine Hydrochloride is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Epinastine Hydrochloride.

Product ID51991-836_5444140d-d869-4788-9b15-85138b765094
NDC51991-836
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 NameBreckenridge Pharmaceutical, Inc.
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 Through2021-12-31

Packaging

NDC 51991-836-75

1 BOTTLE, DROPPER in 1 CARTON (51991-836-75) > 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2013-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-836-75 [51991083675]

Epinastine Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA090870
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-11-05

Drug Details

Active Ingredients

IngredientStrength
EPINASTINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:8ff37968-22a1-4904-a139-977463790f12
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860654
    • UPC Code
  • 0351991836759

    • Pharmacological Class

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

    Medicade Reported Pricing

    51991083675 EPINASTINE HCL 0.05% EYE DROPS

    Pricing Unit: ML | Drug Type:

    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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