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  5. NDC Package Code: 53002-1735-3 Drospirenone And Ethinyl Estradiol

NDC Package 53002-1735-3 Drospirenone And Ethinyl Estradiol

Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
53002-1735-3
Package Description:
3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
Product Code:
53002-1735
Proprietary Name:
Drospirenone And Ethinyl Estradiol
Non-Proprietary Name:
Drospirenone And Ethinyl Estradiol
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)].
11-Digit NDC Billing Format:
53002173503
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA204296
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-17-2015
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53002-1735-11 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK
    53002-1735-66 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-1735-3?

    The NDC Packaged Code 53002-1735-3 is assigned to a package of 3 blister pack in 1 package / 1 kit in 1 blister pack of Drospirenone And Ethinyl Estradiol, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 53002-1735 included in the NDC Directory?

    Yes, Drospirenone And Ethinyl Estradiol with product code 53002-1735 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on August 17, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53002-1735-3?

    The 11-digit format is 53002173503. 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 5-4-1 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
    5-4-153002-1735-35-4-253002-1735-03