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  5. NDC Package Code: 65862-940-58 Aurovela Fe 1/20

NDC Package 65862-940-58 Aurovela Fe 1/20

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65862-940-58
Package Description:
5 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code:
65862-940
Proprietary Name:
Aurovela Fe 1/20
Non-Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
Usage Information:
Aurovela Fe 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)  Oral contraceptives       combined       progestin only  Diaphragm with spermicidal        cream or jelly   Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) Vaginal Sponge       nulliparous       parous  Implant  Injection: depot medroxyprogesterone acetate  IUD       progesterone T       copper T 380A       LNg 20  Condom without spermicides       female       male  Cervical Cap with spermicidal       cream or jelly       nulliparous        parous  Periodic abstinence (all methods)  Withdrawal  Female sterilization  Male sterilization(85) 0.10.5 669200.050.3 1.50.60.1 53  9261 to 940.50.1(85)3N/A***N/A*** 202620400.050.3 20.80.1 2114  204025190.50.15
11-Digit NDC Billing Format:
65862094058
NDC to 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: 1358763 - {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1358763 - Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA207505
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-16-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65862-940-883 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (65862-940-87) / 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-940-58?

    The NDC Packaged Code 65862-940-58 is assigned to a package of 5 pouch in 1 carton / 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Aurovela Fe 1/20, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is kit and is administered via form.

    Is NDC 65862-940 included in the NDC Directory?

    Yes, Aurovela Fe 1/20 with product code 65862-940 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on June 16, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65862-940-58?

    The 11-digit format is 65862094058. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265862-940-585-4-265862-0940-58