NDC 0093-6031 Rivelsa

Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0093-6031
Proprietary Name:
Rivelsa
Non-Proprietary Name: [1]
Levonorgestrel/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]
Teva Pharmaceuticals Usa, Inc.
Labeler Code:
0093
FDA Application Number: [6]
NDA204061
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date: [9]
04-03-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328 - LIGHT PINK)
PINK (C48328)
PURPLE (C48327)
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
TV;076
TV;075
TV;074
TV;077
Score:
1

Product Packages

NDC Code 0093-6031-82

Package Description: 2 POUCH in 1 CARTON / 1 KIT in 1 POUCH (0093-6031-91)

Product Details

What is NDC 0093-6031?

The NDC code 0093-6031 is assigned by the FDA to the product Rivelsa which is a human prescription drug product labeled by Teva Pharmaceuticals Usa, Inc.. The generic name of Rivelsa is levonorgestrel/ethinyl estradiol and ethinyl estradiol. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0093-6031-82 2 pouch in 1 carton / 1 kit in 1 pouch (0093-6031-91). 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 Rivelsa?

This combination hormone medication is used to prevent pregnancy. It contains 2 hormones: a progestin (levonorgestrel) and an estrogen (ethinyl estradiol). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Which are Rivelsa UNII Codes?

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

Which are Rivelsa 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 Rivelsa?

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: 1876397 - {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 [Rivelsa 91 Day]

* 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".