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  5. NDC Package Code: 0378-6550-53 Levonorgestrel And Ethinyl Estradiol

NDC Package 0378-6550-53 Levonorgestrel And Ethinyl Estradiol

Kit - 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:
0378-6550-53
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-6550-85) / 1 KIT in 1 BLISTER PACK
Product Code:
0378-6550
Proprietary Name:
Levonorgestrel And Ethinyl Estradiol
Non-Proprietary Name:
Levonorgestrel And Ethinyl Estradiol
Usage Information:
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHODMethodPerfect UseTypical UseLevonorgestrel implants0.050.05Male sterilization0.10.15Female sterilization0.50.5Depo-Provera®(injectable progestogen)0.30.3Oral contraceptives5           Combined0.1NA           Progestin only0.5NAIUD           Progesterone1.52.0           Copper T 380A0.60.8Condom (male) without spermicide314           (Female) without spermicide521Cervical cap           Nulliparous women920           Parous women2640Vaginal sponge           Nulliparous women920           Parous women2040Diaphragm with spermicidal cream or jelly620Spermicides alone (foam, creams, jellies, and vaginal     suppositories)626Periodic abstinence (all methods)1 to 9a25Withdrawal419No contraception (planned pregnancy)8585NA- not available a Depending on method (calendar, ovulation, symptothermal, post-ovulation)Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition.NY, NY: Ardent Media, Inc., 1998.
11-Digit NDC Billing Format:
00378655053
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: 238019 - levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet
  • RxCUI: 238019 - ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
  • RxCUI: 748878 - {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA091663
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-16-2013
    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.

    Frequently Asked Questions

    What is NDC 0378-6550-53?

    The NDC Packaged Code 0378-6550-53 is assigned to a package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-6550-85) / 1 kit in 1 blister pack of Levonorgestrel And Ethinyl Estradiol, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 0378-6550 included in the NDC Directory?

    Yes, Levonorgestrel And Ethinyl Estradiol with product code 0378-6550 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on August 16, 2013 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 NDC billing unit for package 0378-6550-53?

    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 0378-6550-53?

    The 11-digit format is 00378655053. 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
    4-4-20378-6550-535-4-200378-6550-53