Levonorgestrel And Ethinyl Estradiol Kit
NDC 0378-6550

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0378-6550?
  5. Levonorgestrel 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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Levonorgestrel And Ethinyl Estradiol is a ANDA-approved product labeled by Mylan Pharmaceuticals Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white kit. This product entry covers the primary NDC 0378-6550 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0378-6550
Proprietary Name:
Levonorgestrel And Ethinyl Estradiol
Non-Proprietary Name: [1]
Levonorgestrel And Ethinyl Estradiol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Mylan Pharmaceuticals Inc.
Labeler Code:
0378
Product Label ID:
27178b07-42bd-496d-aebb-d9428664ee72
FDA Application Number: [6]
ANDA091663
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
08-16-2013
End Marketing Date: [10]
06-30-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
GREEN (C48329)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
209
274
Score:
1

Code Structure Chart

Product Details

What is NDC 0378-6550?

The NDC code 0378-6550 is assigned by the FDA to the product Levonorgestrel And Ethinyl Estradiol. This pharmaceutical product is labeled by Mylan Pharmaceuticals Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0378-6550-53. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHODMethodPerfect UseTypical UseLevonorgestrel implants0.050.05Male sterilization0.10.15Female sterilization0.50.5Depo-Provera®(injectable progestogen)0.30.3Oral contraceptives5           Combined0.1NA           Progestin only0.5NAIUD           Progesterone1.52.0           Copper T 380A0.60.8Condom (male) without spermicide314           (Female) without spermicide521Cervical cap           Nulliparous women920           Parous women2640Vaginal sponge           Nulliparous women920           Parous women2040Diaphragm with spermicidal cream or jelly620Spermicides alone (foam, creams, jellies, and vaginal     suppositories)626Periodic abstinence (all methods)1 to 9a25Withdrawal419No contraception (planned pregnancy)8585NA- not available a Depending on method (calendar, ovulation, symptothermal, post-ovulation)Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition.NY, NY: Ardent Media, Inc., 1998.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 238019 - levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet
  • RxCUI: 238019 - ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
  • RxCUI: 748878 - {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack

* Please review the full disclaimer at the bottom of this page.

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".