NDC 60505-0584

Epinastine Hydrochloride

Epinastine Hydrochloride

Epinastine Hydrochloride is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Epinastine Hydrochloride.

• Product ID: 60505-0584_838f525d-0f34-8f20-9364-7aaf36a42c32
• NDC: 60505-0584
• Product Type: Human Prescription Drug
• Proprietary Name: Epinastine Hydrochloride
• Generic Name: Epinastine Hydrochloride
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2011-10-31
• Marketing End Date: 2021-03-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090919
• Labeler Name: Apotex Corp.
• Substance Name: EPINASTINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
• NDC Exclude Flag: N

Packaging

NDC 60505-0584-1

1 BOTTLE, PLASTIC in 1 CARTON (60505-0584-1) > 5 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2011-10-31
• Marketing End Date: 2021-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60505-0584-1 [60505058401]

Epinastine Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090919
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-10-31
• Marketing End Date: 2021-03-01

Drug Details

Active Ingredients

Ingredient	Strength
EPINASTINE HYDROCHLORIDE	.5 mg/mL

OpenFDA Data

• SPL SET ID: df001833-f478-ee51-325a-9e1b56199567
• Manufacturer:
  • Apotex Corp.
• UNII:
  • GFM415S5XL
• 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

60505058401 EPINASTINE HCL 0.05% EYE DROPS

Pricing Unit: ML | Drug Type:

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

NDC	Brand Name	Generic Name
50090-1635	Epinastine Hydrochloride	Epinastine Hydrochloride
51991-836	Epinastine Hydrochloride	Epinastine Hydrochloride
60505-0584	Epinastine Hydrochloride	Epinastine Hydrochloride
62756-329	EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE
70069-008	EPINASTINE HYDROCHLORIDE	EPINASTINE HYDROCHLORIDE
0023-9201	ELESTAT	epinastine hydrochloride
17478-911	Epinastine	Epinastine Hydrochloride