Balcoltra Kit
NDC Package 75854-602-28

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

Package Information

Balcoltra (levonorgestrel and ethinyl estradiol) kits is this combination hormone medication is used to prevent pregnancy. This formulation utilizes a kit delivery system. Marketed by Avion Pharmaceuticals, this product is identified by NDC 75854-602 and is authorized under FDA application NDA208612.

Identification & Billing

NDC Package Code
75854-602-28
Package Description
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
11-Digit Billing Format
75854060228
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1999026 - {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Balcoltra 28 Day]
  • RxCUI: 1999026 - Balcoltra 28 Day Pack
  • RxCUI: 242297 - levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 242297 - ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet
  • RxCUI: 2672922 - ferrous bisglycinate 36.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Balcoltra
Non-Proprietary Name
Levonorgestrel And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). 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. There is a small amount of iron in each of the 7 inactive tablets taken during the fourth week. The inactive pills do not contain any hormones. These tablets are meant to keep you in the habit of taking 1 tablet each day and do not have enough iron to treat iron deficiency. 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. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity.

Regulatory & Marketing

Labeler Name
Avion Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA208612
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-10-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (75854-602). Click a package code to view its specific billing and regulatory data.

2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

* 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 75854-602-28 identifies a specific commercial package of 1 blister pack in 1 carton / 1 kit in 1 blister pack of Balcoltra, a human prescription drug labeled by Avion Pharmaceuticals. 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 Avion Pharmaceuticals on April 10, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). 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. There is a small amount of iron in each of the 7 inactive tablets taken during the fourth week. The inactive pills do not contain any hormones. These tablets are meant to keep you in the habit of taking 1 tablet each day and do not have enough iron to treat iron deficiency. 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. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity.

How is this Avion Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75854060228. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
75854-602-28
11-Digit CMS (5-4-2)
75854-0602-28

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