epinastine hydrochloride

Generic: epinastine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name epinastine hydrochloride
Generic Name epinastine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

epinastine hydrochloride .5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-008
Product ID 70069-008_a873a505-bb9c-4430-8921-8d800df991c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090951
Listing Expiration 2026-12-31
Marketing Start 2016-09-14

Pharmacologic Class

Classes
adrenergic agonists [moa] adrenergic receptor agonist [epc] decreased histamine release [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069008
Hyphenated Format 70069-008

Supplemental Identifiers

RxCUI
860654
UPC
0370069008010
UNII
GFM415S5XL

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name epinastine hydrochloride (source: ndc)
Generic Name epinastine hydrochloride (source: ndc)
Application Number ANDA090951 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-008-01 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE

Ingredients (1)

epinastine hydrochloride (.5 mg/mL)

Linked Drug Pages (1)

EPINASTINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "a873a505-bb9c-4430-8921-8d800df991c7", "openfda": {"upc": ["0370069008010"], "unii": ["GFM415S5XL"], "rxcui": ["860654"], "spl_set_id": ["0d4ee45c-e58f-4b7c-b389-898f5c27f54d"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-008-01)  / 5 mL in 1 BOTTLE", "package_ndc": "70069-008-01", "marketing_start_date": "20160914"}], "brand_name": "EPINASTINE HYDROCHLORIDE", "product_id": "70069-008_a873a505-bb9c-4430-8921-8d800df991c7", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic Agonists [MoA]", "Adrenergic Receptor Agonist [EPC]", "Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "70069-008", "generic_name": "EPINASTINE HYDROCHLORIDE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPINASTINE HYDROCHLORIDE", "active_ingredients": [{"name": "EPINASTINE HYDROCHLORIDE", "strength": ".5 mg/mL"}], "application_number": "ANDA090951", "marketing_category": "ANDA", "marketing_start_date": "20160914", "listing_expiration_date": "20261231"}