NDC Package 61916-090-30 Drospirenone And Ethinyl Estradiol

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

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:
61916-090-30
Package Description:
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code:
Proprietary Name:
Drospirenone And Ethinyl Estradiol
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)]
11-Digit NDC Billing Format:
61916009030
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
Labeler Name:
Pharmaceutics International, Inc. (pii)
Sample Package:
No
FDA Application Number:
ANDA203291
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-26-2017
Listing Expiration Date:
12-31-2023
Exclude Flag:
I
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.

Frequently Asked Questions

What is NDC 61916-090-30?

The NDC Packaged Code 61916-090-30 is assigned to a 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). The product's dosage form is and is administered via form.

Is NDC 61916-090 included in the NDC Directory?

No, Drospirenone And Ethinyl Estradiol with product code 61916-090 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Pharmaceutics International, Inc. (pii) on October 26, 2017 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 61916-090-30?

The 11-digit format is 61916009030. 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 5-3-2 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
5-3-261916-090-305-4-261916-0090-30