Aurovela 1/20 Tablet
NDC Package 65862-939-54

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

Package Information

Aurovela 1/20 (norethindrone acetate and ethinyl estradiol) tablets is aurovela 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. This formulation utilizes a tablet delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-939 and is authorized under FDA application ANDA207506.

Identification & Billing

NDC Package Code
65862-939-54
Package Description
5 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
Product Code
65862-939
11-Digit Billing Format
65862093954
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
Aurovela 1/20
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
Aurovela 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7.*The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.** This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. *** N/A-Data not available. %  Of  Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use MethodLowest Expected*Typical** (No contraception)(85)(85) Oral contraceptives 3    Combined0.1N/A***    progestin only0.5N/A*** Diaphragm with spermicidal cream or jelly 620 Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)626 Vaginal Sponge      nulliparous920    parous2040 Implant0.050.05 Injection: depot medroxyprogesterone acetate0.30.3 IUD        progesterone T1.52      copper T 380A0.60.8      LNg 200.10.1 Condom without spermicides        female521      male314 Cervical Cap with spermicidal cream or jelly        nulliparous 920      parous2640 Periodic abstinence (all methods)1 to 925 Withdrawal419 Female sterilization0.50.5 Male sterilization0.10.15

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207506
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-16-2017
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 (65862-939). Click a package code to view its specific billing and regulatory data.

65862-939-88
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 21 TABLET 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 65862-939-54 identifies a specific commercial package of 5 pouch in 1 carton / 1 blister pack in 1 pouch / 21 tablet in 1 blister pack of Aurovela 1/20, a human prescription drug labeled by Aurobindo Pharma Limited. 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 Aurobindo Pharma Limited on June 16, 2017. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862093954. 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)
65862-939-54
11-Digit CMS (5-4-2)
65862-0939-54

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