Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate Kit
NDC Package 68462-376-29

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate kits is norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. This formulation utilizes a kit delivery system. Marketed by Glenmark Pharmaceuticals Inc., Usa, this product is identified by NDC 68462-376 and is authorized under FDA application ANDA210369.

Identification & Billing

NDC Package Code
68462-376-29
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
68462-376
11-Digit Billing Format
68462037629
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
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

Clinical Specifications

Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
Non-Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.

Regulatory & Marketing

Labeler Name
Glenmark Pharmaceuticals Inc., Usa
Product Type
Human Prescription Drug
FDA Application #
ANDA210369
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-26-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68462-376-29 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Glenmark Pharmaceuticals Inc., Usa on December 26, 2017. The current certification is valid through December 31, 2026.

How is this Glenmark Pharmaceuticals Inc., Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68462037629. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68462-376-29
11-Digit CMS (5-4-2)
68462-0376-29

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.