Vestura
NDC Package 0093-4000-62

11-digit billing NDC: 00093400062 · Billing unit: EA · 3 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Vestura is do not prescribe Vestura to women who are known to have the following:Renal impairmentAdrenal insufficiencyA high risk of arterial or venous thrombotic diseases. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-4000 and is authorized under FDA application ANDA078833.

Identification & Billing

NDC Package Code
0093-4000-62
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22)
Product Code
0093-4000
11-Digit Billing Format
00093400062
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA

Clinical Specifications

Proprietary Name
Vestura
Dosage Form
-
Usage Information
Do not prescribe Vestura to women who are known to have the following:Renal impairmentAdrenal insufficiencyA 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)]Use of Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations [see Warnings and Precautions (5.5) and Drug Interactions (7.3)].

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
FDA Application #
ANDA078833
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-02-2021
End Marketing Date
05-31-2026
Listing Expiration
05-31-2026
Exclude Flag
D
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 0093-4000-62 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack (0093-4000-28) * 24 tablet in 1 blister pack (0093-3634-11) * 4 tablet in 1 blister pack (0093-3622-22) of Vestura, labeled by Teva Pharmaceuticals Usa, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Teva Pharmaceuticals Usa, Inc. on March 02, 2021. The current certification is valid through May 31, 2026.

How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093400062. 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)
0093-4000-62
11-Digit CMS (5-4-2)
00093-4000-62

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