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  5. NDC Package Code: 0781-4110-15 Estradiol Valerate And Estradiol Valerate/dienogest

NDC Package 0781-4110-15 Estradiol Valerate And Estradiol Valerate/dienogest

Kit - 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:
0781-4110-15
Package Description:
3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (0781-4110-52)
Product Code:
0781-4110
Proprietary Name:
Estradiol Valerate And Estradiol Valerate/dienogest
Non-Proprietary Name:
Estradiol Valerate And Estradiol Valerate/dienogest
Usage Information:
Do not prescribe Estradiol Valerate and Estradiol Valerate/Dienogest to women who are known to have the following:•A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: •Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]•Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]•Have cerebrovascular disease [see Warnings and Precautions (5.1)]•Have coronary artery disease [see Warnings and Precautions (5.1)]•Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]•Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]•Have uncontrolled hypertension [see Warnings and Precautions (5.4)]•Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]•Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.7)]•Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]•Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.2)]•Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].•Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)].
11-Digit NDC Billing Format:
00781411015
NDC to RxNorm Crosswalk:
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
  • RxCUI: 978941 - estradiol valerate 3 MG Oral Tablet
  • RxCUI: 978944 - dienogest 2 MG / estradiol valerate 2 MG Oral Tablet
  • RxCUI: 978946 - dienogest 3 MG / estradiol valerate 2 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA022252
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    08-05-2015
    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 0781-4110-15?

    The NDC Packaged Code 0781-4110-15 is assigned to a package of 3 blister pack in 1 package / 1 kit in 1 blister pack (0781-4110-52) of Estradiol Valerate And Estradiol Valerate/dienogest, a human prescription drug labeled by Sandoz Inc. The product's dosage form is kit and is administered via form.

    Is NDC 0781-4110 included in the NDC Directory?

    Yes, Estradiol Valerate And Estradiol Valerate/dienogest with product code 0781-4110 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on August 05, 2015 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 0781-4110-15?

    The 11-digit format is 00781411015. 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 4-4-2 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
    4-4-20781-4110-155-4-200781-4110-15