Gianvi
NDC Package 0093-5423-58

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Gianvi is a medication a combination of 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). Marketed by Teva Pharmaceuticals Usa Inc, this product is identified by NDC 0093-5423 and is authorized under FDA application NDA021676.

Identification & Billing

NDC Package Code
0093-5423-58
Package Description
3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (0093-5423-28)
Product Code
11-Digit Billing Format
00093542358
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
Gianvi
Dosage Form
-
Usage Information
This medication is a combination of 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). This product is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also may be used to treat premenstrual dysphoric disorder (PMDD) or moderate acne if you have chosen to use birth control pills as your method of pregnancy prevention. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, and decrease your risk of ovarian cysts. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa Inc
FDA Application #
NDA021676
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
03-30-2011
End Marketing Date
06-23-2023
Listing Expiration
06-23-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0093-5423). Click a package code to view its specific billing and regulatory data.

3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (0093-5423-28)

* 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 0093-5423-58 identifies a specific commercial package of 3 blister pack in 1 package / 1 kit in 1 blister pack (0093-5423-28) of Gianvi, 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 30, 2011. The current certification is valid through June 23, 2023.

What are the primary indications for this medication?

This medication is a combination of 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). This product is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. This medication also may be used to treat premenstrual dysphoric disorder (PMDD) or moderate acne if you have chosen to use birth control pills as your method of pregnancy prevention. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, and decrease your risk of ovarian cysts. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

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: 00093542358. 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)
0093-5423-58
11-Digit CMS (5-4-2)
00093-5423-58

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