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  4. NDC Product Code: 71205-170 Norgestimate And Ethinyl Estradiol

NDC 71205-170 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 71205-170?
  5. Norgestimate And Ethinyl Estradiol Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 71205-170 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
71205-170
Proprietary Name:
Norgestimate And Ethinyl Estradiol
Product Type: [3]
Labeler Name: [5]
Proficient Rx Lp
Labeler Code:
71205
Product Label ID:
4c5034e5-f247-4961-870d-60c67149d51a
FDA Application Number: [6]
ANDA200383
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
11-15-2016
End Marketing Date: [10]
05-18-2022
Listing Expiration Date: [11]
05-18-2022
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE)
BLUE (C48333 - MEDIUM BLUE)
BLUE (C48333 - BLUE)
WHITE (C48325 - WHITE)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
12
13
14
11
Score:
1

Code Structure Chart

Product Details

What is NDC 71205-170?

The NDC code 71205-170 is assigned by the FDA to the product Norgestimate And Ethinyl Estradiol which is product labeled by Proficient Rx Lp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 71205-170-28 1 blister pack in 1 carton / 1 kit in 1 blister pack * 7 tablet in 1 blister pack * 7 tablet in 1 blister pack * 7 tablet in 1 blister pack * 7 tablet 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 USP 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:

* 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.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".