Isibloom Kit
NDC Package 70700-113-85

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

Package Information

Isibloom (desogestrel and ethinyl estradiol) kits is this combination hormone medication is used to prevent pregnancy. This formulation utilizes a kit delivery system. Marketed by Xiromed, Llc., this product is identified by NDC 70700-113 and is authorized under FDA application ANDA202789.

Identification & Billing

NDC Package Code
70700-113-85
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
70700-113
11-Digit Billing Format
70700011385
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: 1866047 - {21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Isibloom 28 Day]
  • RxCUI: 1866047 - Isibloom 28 Day Pack
  • RxCUI: 240707 - desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet

Clinical Specifications

Proprietary Name
Isibloom
Non-Proprietary Name
Desogestrel 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: a progestin and 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. If a fertilized egg does not attach to the uterus, it passes out of the body. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Regulatory & Marketing

Labeler Name
Xiromed, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202789
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70700-113-85 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Isibloom, a human prescription drug labeled by Xiromed, Llc.. 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 Xiromed, Llc. on February 01, 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: a progestin and 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. If a fertilized egg does not attach to the uterus, it passes out of the body. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

How is this Xiromed, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70700011385. 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 (5-3-2)
70700-113-85
11-Digit CMS (5-4-2)
70700-0113-85

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