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

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium kits is 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. This formulation utilizes a kit delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-4075 and is authorized under FDA application NDA022532.

Identification & Billing

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
11-Digit Billing Format
00781407515
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
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

Clinical Specifications

Proprietary Name
Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium
Non-Proprietary Name
Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium
Dosage Form
Kit - A packaged collection of related material.
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)]

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
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
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0781-4075-15 identifies a specific commercial 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. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sandoz Inc on October 12, 2016. The current certification is valid through December 31, 2026.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781407515. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0781-4075-15
11-Digit CMS (5-4-2)
00781-4075-15

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.