Drospirenone And Ethinyl Estradiol
NDC Package 53002-1735-3

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.

Drospirenone And Ethinyl Estradiol is do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following:•Renal impairment•Adrenal insufficiency•A high risk of arterial or venous thrombotic diseases. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-1735 and is authorized under FDA application ANDA204296.

Identification & Billing

NDC Package Code
53002-1735-3
Package Description
3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
Product Code
53002-1735
11-Digit Billing Format
53002173503
RxNorm Crosswalk
  • RxCUI: 630734 - drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
  • RxCUI: 748798 - {24 (drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack
  • RxCUI: 748798 - Drospiren-Eth estra 3-0.02 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Drospirenone And Ethinyl Estradiol
Dosage Form
-
Usage Information
Do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following:•Renal impairment•Adrenal insufficiency•A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:oSmoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] oHave deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]oHave cerebrovascular disease [see Warnings and Precautions (5.1)]oHave coronary artery disease [see Warnings and Precautions (5.1)]oHave thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]oHave inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]oHave uncontrolled hypertension [see Warnings and Precautions (5.6)]oHave diabetes mellitus with vascular disease [see Warnings and Precautions (5.8)]oHave headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.9)]•Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.10)]•Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.3)]•Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.4) and Use in Specific Populations (8.7)]•Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1)]•Use of Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations [see Warnings and Precautions (5.6) and Drug Interactions (7.3)].

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA204296
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-17-2015
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 (53002-1735). Click a package code to view its specific billing and regulatory data.

53002-1735-1
1 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
53002-1735-6
6 BLISTER PACK in 1 PACKAGE / 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 53002-1735-3 identifies a specific commercial package of 3 blister pack in 1 package / 1 kit in 1 blister pack of Drospirenone And Ethinyl Estradiol, 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 August 17, 2015. 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: 53002173503. 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)
53002-1735-3
11-Digit CMS (5-4-2)
53002-1735-03

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