NDC 17478-911

Epinastine

Epinastine Hydrochloride

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

Product ID17478-911_0239697b-0d90-43f7-92be-4af4f7273c95
NDC17478-911
Product TypeHuman Prescription Drug
Proprietary NameEpinastine
Generic NameEpinastine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2017-05-05
Marketing CategoryANDA / ANDA
Application NumberANDA204055
Labeler NameAkorn, 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 Through2020-12-31

Packaging

NDC 17478-911-05

5 mL in 1 BOTTLE, DROPPER (17478-911-05)
Marketing Start Date2017-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-911-05 [17478091105]

Epinastine SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA204055
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-05

Drug Details

Active Ingredients

IngredientStrength
EPINASTINE HYDROCHLORIDE.5 mg/mL

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]

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

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

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