Drospirenone And Ethinyl Estradiol
NDC Package 61916-090-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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, USP 3 mg/0.02 mg to women who are known to have the following: Renal impairment Adrenal insufficiency A high risk of arterial or venous thrombotic diseases. Marketed by Pharmaceutics International, Inc. (pii), this product is identified by NDC 61916-090 and is authorized under FDA application ANDA203291.

Identification & Billing

NDC Package Code
61916-090-30
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
61916-090
11-Digit Billing Format
61916009030
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, USP 3 mg/0.02 mg 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:Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]Have cerebrovascular disease [see Warnings and Precautions (5.1)]Have coronary artery disease [see Warnings and Precautions (5.1)]Have 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)]Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]Have uncontrolled hypertension [see Warnings and Precautions (5.5)]Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7)]Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8)]Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)]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 (5.10) and Use in Specific Populations (8.1)]

Regulatory & Marketing

Labeler Name
Pharmaceutics International, Inc. (pii)
FDA Application #
ANDA203291
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-26-2017
Listing Expiration
12-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61916-090-30 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Drospirenone And Ethinyl Estradiol, labeled by Pharmaceutics International, Inc. (pii). 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 Pharmaceutics International, Inc. (pii) on October 26, 2017. The current certification is valid through December 31, 2023.

How is this Pharmaceutics International, Inc. (pii) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61916009030. 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)
61916-090-30
11-Digit CMS (5-4-2)
61916-0090-30

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