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  5. NDC Package Code: 70069-008-10 Epinastine Hydrochloride

NDC Package 70069-008-10 Epinastine Hydrochloride

Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70069-008-10
Package Description:
10 CARTON in 1 CARTON / 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE
Product Code:
70069-008
Proprietary Name:
Epinastine Hydrochloride
Non-Proprietary Name:
Epinastine Hydrochloride
Substance Name:
Epinastine Hydrochloride
11-Digit NDC Billing Format:
70069000810
NDC to RxNorm Crosswalk:
  • RxCUI: 860654 - epinastine HCl 0.05 % Ophthalmic Solution
  • RxCUI: 860654 - epinastine hydrochloride 0.5 MG/ML Ophthalmic Solution
  • RxCUI: 860654 - epinastine hydrochloride 0.05 % (as epinastine 0.044 % ) Ophthalmic Solution
  • RxCUI: 860654 - epinastine hydrochloride 0.05 % Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Somerset Therapeutics, Llc
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • EPINASTINE HYDROCHLORIDE .5 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic Agonists - [MoA] (Mechanism of Action)
  • Adrenergic Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Decreased Histamine Release - [PE] (Physiologic Effect)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090951
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-14-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70069-008-10?

    The NDC Packaged Code 70069-008-10 is assigned to a package of 10 carton in 1 carton / 1 bottle in 1 carton (70069-008-01) / 5 ml in 1 bottle of Epinastine Hydrochloride, a human prescription drug labeled by Somerset Therapeutics, Llc. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 70069-008 included in the NDC Directory?

    Yes, Epinastine Hydrochloride with product code 70069-008 is active and included in the NDC Directory. The product was first marketed by Somerset Therapeutics, Llc on September 14, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70069-008-10?

    The 11-digit format is 70069000810. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-270069-008-105-4-270069-0008-10