NDC 0023-9201

ELESTAT

Epinastine Hydrochloride

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

• Product ID: 0023-9201_75ad94a2-5508-443e-8143-2bb27a7e2466
• NDC: 0023-9201
• Product Type: Human Prescription Drug
• Proprietary Name: ELESTAT
• Generic Name: Epinastine Hydrochloride
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2004-01-19
• Marketing Category: NDA / NDA
• Application Number: NDA021565
• Labeler Name: Allergan, Inc.
• 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
• Listing Certified Through: 2019-12-31

Packaging

NDC 0023-9201-05

1 BOTTLE, DROPPER in 1 CARTON (0023-9201-05) > 5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2004-01-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-9201-05 [00023920105]

ELESTAT SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA021565
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2004-01-19
• Marketing End Date: 2019-05-31

NDC 0023-9201-01 [00023920101]

ELESTAT SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA021565
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-08-14
• Marketing End Date: 2012-01-19

Drug Details

Active Ingredients

Ingredient	Strength
EPINASTINE HYDROCHLORIDE	.5 mg/mL

OpenFDA Data

• SPL SET ID: a9628ec7-bbeb-4cfa-932f-645a8aca8987
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • GFM415S5XL
• RxNorm Concept Unique ID - RxCUI:
  • 860654
  • 860656
• UPC Code:
  • 0300239201057

Pharmacological Class

• 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 "ELESTAT" or generic name "Epinastine Hydrochloride"

NDC	Brand Name	Generic Name
0023-9201	ELESTAT	epinastine hydrochloride
17478-911	Epinastine	Epinastine Hydrochloride
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