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  5. NDC Package Code: 65862-935-54 Aurovela 1.5/30

NDC Package 65862-935-54 Aurovela 1.5/30

Norethindrone Acetate And Ethinyl Estradiol Tablet Oral - 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:
65862-935-54
Package Description:
5 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
Product Code:
65862-935
Proprietary Name:
Aurovela 1.5/30
Non-Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol
Substance Name:
Ethinyl Estradiol; Norethindrone Acetate
Usage Information:
Aurovela 1.5/30 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) 0.10.566 9200.050.3 1.50.60.1 53 9261 to 940.50.1(85)3N/A***N/A***2026 20400.050.3 20.80.1 2114 204025190.50.15
11-Digit NDC Billing Format:
65862093554
NDC to RxNorm Crosswalk:
  • RxCUI: 1359022 - norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359022 - ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet
  • RxCUI: 1359028 - {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } Pack
  • RxCUI: 1359028 - Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet 21 Day Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ETHINYL ESTRADIOL 30 ug/1
  • NORETHINDRONE ACETATE 1.5 mg/1
    • Pharmacologic Class(es):
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA207581
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-26-2017
    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
    65862-935-743 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-935-54?

    The NDC Packaged Code 65862-935-54 is assigned to a package of 5 pouch in 1 carton / 1 blister pack in 1 pouch / 21 tablet in 1 blister pack of Aurovela 1.5/30, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65862-935 included in the NDC Directory?

    Yes, Aurovela 1.5/30 with product code 65862-935 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on June 26, 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 65862-935-54?

    The 11-digit format is 65862093554. 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
    5-3-265862-935-545-4-265862-0935-54