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  5. NDC Package Code: 0378-7274-53 Norethindrone Acetate And Ethinyl Estradiol

NDC Package 0378-7274-53 Norethindrone Acetate And Ethinyl Estradiol

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0378-7274-53
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-7274-85) / 21 TABLET in 1 BLISTER PACK
Product Code:
0378-7274
Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol
Non-Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol
Substance Name:
Ethinyl Estradiol; Norethindrone Acetate
Usage Information:
Norethindrone Acetate and Ethinyl Estradiol Tablets are 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% of Women Experiencing an Unintended Pregnancyin the First Year of Continuous UseMethodLowest Expected*Typical**(No contraception) (85)(85)Oral contraceptives 3combined 0.1N/A ***progestin only 0.5N/A ***Diaphragm with spermicidal cream or jelly 620Spermicides alone (foam, creams, gels, vaginal suppositories and vaginal film) 626Vaginal Spongenulliparous 920parous2040Implant 0.050.05Injection: depot medroxyprogesterone acetate 0.30.3IUDprogesterone T 1.52.0copper T 380A 0.60.8LNg 20 0.10.1Condom without spermicidesfemale 521male 314Cervical Cap with spermicidal cream or jellynulliparous 920parous 2640Periodic abstinence (all methods) 1-925Withdrawal 419Female sterilization 0.50.5Male sterilization 0.100.15Adapted 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.
11-Digit NDC Billing Format:
00378727453
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
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:
    Mylan Pharmaceuticals Inc.
    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 .03 mg/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:
    ANDA202770
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-25-2019
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 0378-7274-53?

    The NDC Packaged Code 0378-7274-53 is assigned to a package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-7274-85) / 21 tablet in 1 blister pack of Norethindrone Acetate And Ethinyl Estradiol, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0378-7274 included in the NDC Directory?

    Yes, Norethindrone Acetate And Ethinyl Estradiol with product code 0378-7274 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on September 25, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0378-7274-53?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 0378-7274-53?

    The 11-digit format is 00378727453. 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 4-4-2 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
    4-4-20378-7274-535-4-200378-7274-53