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  5. NDC Package Code: 59651-504-88 Oshih

NDC Package 59651-504-88 Oshih

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate 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:
59651-504-88
Package Description:
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code:
59651-504
Proprietary Name:
Oshih
Non-Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
Usage Information:
 Oshih is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)].The efficacy of Oshih in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
11-Digit NDC Billing Format:
59651050488
NDC to RxNorm Crosswalk:
  • RxCUI: 1426288 - norethindrone acetate 1 MG / ethinyl estradiol 20 MCG Chewable Tablet
  • RxCUI: 1426288 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Chewable Tablet
  • RxCUI: 1426288 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Chewable Tablet
  • RxCUI: 1426600 - {24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Chewable Tablet) / 4 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1426600 - Eth estra-Noreth Ac 0.02-1 MG (24) Chewable Tablet / Ferr fum 75 MG (4) 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:
ANDA216558
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
12-06-2023
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 59651-504-88?

The NDC Packaged Code 59651-504-88 is assigned to a package of 3 pouch in 1 carton / 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Oshih, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is kit and is administered via form.

Is NDC 59651-504 included in the NDC Directory?

Yes, Oshih with product code 59651-504 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on December 06, 2023 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 11-digit format for NDC 59651-504-88?

The 11-digit format is 59651050488. 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
5-3-259651-504-885-4-259651-0504-88