Norethindrone Acetate And Ethinyl Estradiol Kit
NDC Package 0378-7288-53

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 kits is norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate 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. This formulation utilizes a kit delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-7288 and is authorized under FDA application ANDA202741.

Identification & Billing

NDC Package Code
0378-7288-53
Package Description
3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-7288-85) / 1 KIT in 1 BLISTER PACK
Product Code
0378-7288
11-Digit Billing Format
00378728853
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: 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: 1359023 - {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1359023 - Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol
Non-Proprietary Name
Norethindrone Acetate And Ethinyl Estradiol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate 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 METHODAdapted from RA Hatcher et al, Reference 7.% of Women Experiencing an Unintended Pregnancyin the First Year of Continuous UseMethodLowest ExpectedThe 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.TypicalThis 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.(No contraception) (85)(85)Oral contraceptives3      combined 0.1N/AN/A - Data not available.      progestin only 0.5N/ADiaphragm with spermicidal cream or jelly 620Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 626Vaginal Sponge      nulliparous 920      parous2040Implant 0.050.05Injection: depot medroxyprogesterone acetate 0.30.3IUD      progesterone T 1.52      copper T 380A 0.60.8      LNg 20 0.10.1Condom without spermicides      female 521      male 314Cervical Cap with spermicidal cream or jelly      nulliparous 920      parous 2640Periodic abstinence (all methods) 1 to 925Withdrawal 419Female sterilization 0.50.5Male sterilization 0.10.15 

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202741
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2019
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 0378-7288-53 identifies a specific commercial package of 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-7288-85) / 1 kit in 1 blister pack of Norethindrone Acetate And Ethinyl Estradiol, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. 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 Mylan Pharmaceuticals Inc. on December 16, 2019. The current certification is valid through December 31, 2026.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378728853. 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 (4-4-2)
0378-7288-53
11-Digit CMS (5-4-2)
00378-7288-53

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