Tarina Fe 1/20 Eq
NDC Package 53002-3711-3

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tarina Fe 1/20 Eq is tarina Fe 1/20 EQ is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-3711 and is authorized under FDA application ANDA207505.

Identification & Billing

NDC Package Code
53002-3711-3
Package Description
3 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code
53002-3711
11-Digit Billing Format
53002371103
RxNorm Crosswalk
  • RxCUI: 1358762 - norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 1358762 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1358762 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1358763 - {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1358763 - Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Tarina Fe 1/20 Eq
Dosage Form
-
Usage Information
Tarina Fe 1/20 EQ is 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 METHOD% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use   Method Lowest Expected* Typical**   (No contraception) (85) (85)   Oral contraceptives 3        combined 0.1 N/A***        progestin only 0.5 N/A***   Diaphragm with spermicidal cream or jelly 6 20   Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) 6 26   Vaginal Sponge        nulliparous 9 20        parous 20 40   Implant0.050.05  Injection: depot medroxyprogesterone acetate0.30.3  IUD         progesterone T1.52       copper T 380A0.60.8  LNg 200.10.1  Condom without spermicides         female5 21        male314  Cervical Cap with spermicidal cream or jelly          nulliparous 9 20        parous26 40   Periodic abstinence (all methods)1 to 925  Withdrawal419  Female sterilization0.50.5  Male sterilization0.10.15Adapted from RA Hatcher et al, Reference 7. * The 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.** This 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.*** N/A--Data not available.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA207505
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-16-2017
Listing Expiration
12-31-2024
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53002-3711). Click a package code to view its specific billing and regulatory data.

53002-3711-1
1 KIT in 1 BLISTER PACK
53002-3711-6
6 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

* 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 53002-3711-3 identifies a specific commercial package of 3 blister pack in 1 pouch / 1 kit in 1 blister pack of Tarina Fe 1/20 Eq, labeled by Rpk Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rpk Pharmaceuticals, Inc. on June 16, 2017. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002371103. 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 (5-4-1)
53002-3711-3
11-Digit CMS (5-4-2)
53002-3711-03

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