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  4. NDC Product Code: 0378-7316 Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol

NDC 0378-7316 Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0378-7316?
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. 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.

Get all the details for National Drug Code (NDC) 0378-7316 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:
0378-7316
Proprietary Name:
Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol
Non-Proprietary Name: [1]
Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Mylan Pharmaceuticals Inc.
Labeler Code:
0378
Product Label ID:
5c1d0a3a-1b24-44a0-9c53-224365b65945
FDA Application Number: [6]
ANDA206053
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
10-02-2017
End Marketing Date: [10]
08-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
ORANGE (C48331 - LIGHT PEACH)
BLUE (C48333 - BLUISH GREEN)
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
72
73
74
65
Score:
1

Code Structure Chart

Product Details

What is NDC 0378-7316?

The NDC code 0378-7316 is assigned by the FDA to the product Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol which is a human prescription drug product labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0378-7316-85 1 pouch in 1 carton / 1 blister pack in 1 pouch / 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.

Which are Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol UNII Codes?

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

Which are Levonorgestrel And Ethinyl Estradiol 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 Levonorgestrel And Ethinyl Estradiol 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: 1373501 - ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet
  • RxCUI: 1373502 - ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet
  • RxCUI: 1373503 - {7 (ethinyl estradiol 0.01 MG Oral Tablet) / 42 (ethinyl estradiol 0.02 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.025 MG / levonorgestrel 0.15 MG Oral Tablet) / 21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) } Pack
  • RxCUI: 1373503 - Eth estra 0.01 MG (7) Oral Tablet / Eth estra-Levonorgest 0.02-0.15 MG (42) Oral Tablet / Eth estra-Levonorgest 0.025-0.15 MG (21) Oral Tablet / Eth estra-Levonorgest 0.03-0.15 MG (21) Oral Tablet 3 Month Pack
  • RxCUI: 238019 - levonorgestrel 0.15 MG / ethinyl estradiol 0.03 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.
[Learn More]


* 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.

[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.

[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".