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  5. NDC Package Code: 0378-7300-53 Drospirenone And Ethinyl Estradiol

NDC Package 0378-7300-53 Drospirenone 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:
0378-7300-53
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-7300-85) / 1 KIT in 1 BLISTER PACK
Product Code:
0378-7300
Proprietary Name:
Drospirenone And Ethinyl Estradiol
Non-Proprietary Name:
Drospirenone And Ethinyl Estradiol
11-Digit NDC Billing Format:
00378730053
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: 284207 - drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
  • RxCUI: 748800 - {21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack
  • RxCUI: 748800 - Drospiren-Eth estra 3-0.03 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day 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:
    ANDA202131
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-28-2015
    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 0378-7300-53?

    The NDC Packaged Code 0378-7300-53 is assigned to a package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-7300-85) / 1 kit in 1 blister pack of Drospirenone 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 0378-7300 included in the NDC Directory?

    Yes, Drospirenone And Ethinyl Estradiol with product code 0378-7300 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on August 28, 2015 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 0378-7300-53?

    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 0378-7300-53?

    The 11-digit format is 00378730053. 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
    4-4-20378-7300-535-4-200378-7300-53