Junel Tablet
NDC Package 82804-172-21

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

Package Information

Junel (norethindrone acetate and ethinyl estradiol) tablets is this combination hormone medication is used to prevent pregnancy. This formulation utilizes a tablet delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-172 and is authorized under FDA application ANDA076380.

Identification & Billing

NDC Package Code
82804-172-21
Package Description
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
Product Code
82804-172
11-Digit Billing Format
82804017221
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: 1358762 - norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 1358762 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1358762 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1358776 - {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) } Pack
  • RxCUI: 1358776 - Eth estra-Noreth Ac 0.02-1 MG (21) Oral Tablet 21 Day Pack

Clinical Specifications

Proprietary Name
Junel 21 Day
Non-Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol
Substance Name
Ethinyl Estradiol; Norethindrone Acetate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA076380
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-18-2003
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 82804-172-21 identifies a specific commercial package of 3 pouch in 1 carton / 1 blister pack in 1 pouch / 21 tablet in 1 blister pack of Junel 21 Day, a human prescription drug labeled by Proficient Rx Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. This tablet is formulated for oral use and contains ethinyl estradiol; norethindrone acetate 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 Proficient Rx Lp on September 18, 2003. 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 Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804017221. 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)
82804-172-21
11-Digit CMS (5-4-2)
82804-0172-21

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