NDC 70069-008

EPINASTINE HYDROCHLORIDE

Epinastine Hydrochloride

EPINASTINE HYDROCHLORIDE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Somerset Therapeutics, Llc. The primary component is Epinastine Hydrochloride.

Product ID70069-008_775198aa-738b-4d22-813a-4c22e4ff750d
NDC70069-008
Product TypeHuman Prescription Drug
Proprietary NameEPINASTINE HYDROCHLORIDE
Generic NameEpinastine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2016-09-14
Marketing CategoryANDA / ANDA
Application NumberANDA090951
Labeler NameSomerset Therapeutics, LLC
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 Through2022-12-31

Packaging

NDC 70069-008-10

10 CARTON in 1 CARTON (70069-008-10) > 1 BOTTLE in 1 CARTON (70069-008-01) > 5 mL in 1 BOTTLE
Marketing Start Date2016-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-008-01 [70069000801]

EPINASTINE HYDROCHLORIDE SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA090951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-09-14

NDC 70069-008-10 [70069000810]

EPINASTINE HYDROCHLORIDE SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA090951
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-14

Drug Details

Active Ingredients

IngredientStrength
EPINASTINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:0d4ee45c-e58f-4b7c-b389-898f5c27f54d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860654
    • UPC Code
  • 0370069008010

    • 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

    70069000801 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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