NDC 68788-7894 Norgestimate And Ethinyl Estradiol

Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
Proprietary Name:
Norgestimate And Ethinyl Estradiol
Non-Proprietary Name: [1]
Norgestimate And Ethinyl Estradiol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Preferred Pharmaceuticals Inc
Labeler Code:
FDA Application Number: [6]
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
Listing Expiration Date: [11]
Exclude Flag: [12]
Code Structure:
Code Navigator:

Product Characteristics

BLUE (C48333 - LIGHT)
BLUE (C48333)
GREEN (C48329 - LIGHT)
ROUND (C48348)
7 MM

Product Packages

NDC Code 68788-7894-2

Package Description: 1 KIT in 1 BLISTER PACK

Product Details

What is NDC 68788-7894?

The NDC code 68788-7894 is assigned by the FDA to the product Norgestimate And Ethinyl Estradiol which is a human prescription drug product labeled by Preferred Pharmaceuticals Inc. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 68788-7894-2 1 kit in 1 blister pack . 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:
  • RxCUI: 240128 - norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 240128 - ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet
  • RxCUI: 240128 - ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet
  • RxCUI: 406396 - norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 406396 - ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet

* Please review the disclaimer below.

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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* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

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

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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".