Levora
NDC 53002-1565

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53002-1565?
  5. Levora 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.

Levora is a ANDA-approved product labeled by Rpk Pharmaceuticals, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 53002-1565 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53002-1565
Proprietary Name:
Levora
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Rpk Pharmaceuticals, Inc.
Labeler Code:
53002
Product Label ID:
0f2abab7-6dbe-4b18-b001-002b668eb370
FDA Application Number: [6]
ANDA073594
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
08-03-2016
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325)
ORANGE (C48331 - PEACH)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
15;30;WATSON
WATSON;P1
Score:
1

Code Structure Chart

Product Details

What is NDC 53002-1565?

The NDC code 53002-1565 is assigned by the FDA to the product Levora. This pharmaceutical product is labeled by Rpk Pharmaceuticals, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 53002-1565-1, 53002-1565-3, 53002-1565-6. 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 UseNA - not availableLevonorgestrel 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 spongeNulliparous women920Parous women2040Diaphragm with spermicidal cream or jelly620Spermicides alone (foam, creams, jellies, and vaginal suppositories)626Periodic abstinence (all methods)1-9 Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998.25Withdrawal419No contraception (planned pregnancy)8585

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

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

Product & Regulatory Definitions
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 Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
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".