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  4. NDC Product Code: 50090-3733 Norgestimate And Ethinyl Estradiol

NDC 50090-3733 Norgestimate And Ethinyl Estradiol

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50090-3733?
  5. Norgestimate And Ethinyl Estradiol Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50090-3733
Proprietary Name:
Norgestimate And Ethinyl Estradiol
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Product Label ID:
b0c91536-7874-412d-a488-21d65e7340f5
Start Marketing Date: [9]
02-23-2016
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
BLUE (C48333 - LIGHT BLUE)
BLUE (C48333 - BLUE)
GREEN (C48329 - GREEN TO DARK GREEN)
Shape:
ROUND (C48348)
Size(s):
5 MM
Imprint(s):
C8
C7
C6
C9
Score:
1

Product Packages

NDC Code 50090-3733-0

Package Description: 1 KIT in 1 KIT

Product Details

What is NDC 50090-3733?

The NDC code 50090-3733 is assigned by the FDA to the product Norgestimate And Ethinyl Estradiol which is product labeled by A-s Medication Solutions. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50090-3733-0 1 kit in 1 kit . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Norgestimate And Ethinyl Estradiol?

Do not prescribe norgestimate and ethinyl estradiol tablets to women who are known to have the following conditions:•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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see Warnings and Precautions (5.4)]∘Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]∘Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.7)]▪Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]•Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)]•Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]•Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]•Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.11)] •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 (5.3)]

Which are Norgestimate And Ethinyl Estradiol UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Norgestimate And Ethinyl Estradiol Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Norgestimate And Ethinyl Estradiol?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Estrogen and Progestin (Oral Contraceptives)


Oral contraceptives (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Oral contraceptives are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases. Some brands of oral contraceptives are also used to treat acne in certain patients. Oral contraceptives treat acne by decreasing the amounts of certain natural substances that can cause acne. Some oral contraceptives (Beyaz, Yaz) are also used to relieve the symptoms of premenstrual dysphoric disorder (physical and emotional symptoms that occur before the menstrual period each month) in women who have chosen to use an oral contraceptive to prevent pregnancy.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".