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  5. NDC Package Code: 0781-4075-15 Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium

NDC Package 0781-4075-15 Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium

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:
0781-4075-15
Package Description:
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (0781-4075-52)
Product Code:
0781-4075
Proprietary Name:
Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium
Non-Proprietary Name:
Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium
Usage Information:
Do not prescribe Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium to women who are known to have the following:•Renal impairment•Adrenal insufficiency•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 (5.5)]•Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7)]•Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8)]•Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)]•Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.3)]•Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.4) and Use in Specific Populations (8.7)]Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)]
11-Digit NDC Billing Format:
00781407515
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1013626 - drospirenone 3 MG / ethinyl estradiol 0.02 MG / levomefolate calcium 0.451 MG Oral Tablet
  • RxCUI: 1013628 - levomefolate calcium 0.451 MG Oral Tablet
  • RxCUI: 1013629 - {24 (drospirenone 3 MG / ethinyl estradiol 0.02 MG / levomefolate calcium 0.451 MG Oral Tablet) / 4 (levomefolate calcium 0.451 MG Oral Tablet) } Pack
  • RxCUI: 1013629 - Drospiren-Eth estra-Levomefol Ca 3-0.02-0.451 MG (24) Oral Tablet / Levomefol Ca 0.451 MG (4) Oral Tablet 28 Day Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA022532
    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:
    10-12-2016
    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 0781-4075-15?

    The NDC Packaged Code 0781-4075-15 is assigned to a package of 3 blister pack in 1 carton / 1 kit in 1 blister pack (0781-4075-52) of Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium, a human prescription drug labeled by Sandoz Inc. The product's dosage form is kit and is administered via form.

    Is NDC 0781-4075 included in the NDC Directory?

    Yes, Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium with product code 0781-4075 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on October 12, 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 NDC billing unit for package 0781-4075-15?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 0781-4075-15?

    The 11-digit format is 00781407515. 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
    4-4-20781-4075-155-4-200781-4075-15