NDC 62756-329

EPINASTINE HYDROCHLORIDE

Epinastine Hydrochloride

EPINASTINE HYDROCHLORIDE is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Epinastine Hydrochloride.

Product ID62756-329_28c115e2-5923-4870-8a0b-feef3d7ef6ab
NDC62756-329
Product TypeHuman Prescription Drug
Proprietary NameEPINASTINE HYDROCHLORIDE
Generic NameEpinastine Hydrochloride
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2011-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA091626
Labeler NameSun Pharmaceutical Industries, 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 Through2019-12-31

Packaging

NDC 62756-329-90

1 BOTTLE in 1 CARTON (62756-329-90) > 5 mL in 1 BOTTLE
Marketing Start Date2011-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-329-90 [62756032990]

EPINASTINE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA091626
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-11-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
EPINASTINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:cafe4650-6aa4-4466-9beb-064ee5a0e401
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]

    Medicade Reported Pricing

    62756032990 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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