NDC 0555-9025 Junel 21 Day
Norethindrone Acetate And Ethinyl Estradiol Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0555 - Teva Pharmaceuticals Usa, Inc.
- 0555-9025 - Junel
Product Characteristics
Product Packages
NDC Code 0555-9025-42
Package Description: 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
Price per Unit: $0.25116 per EA
Product Details
What is NDC 0555-9025?
What are the uses for Junel 21 Day?
What are Junel 21 Day Active Ingredients?
- ETHINYL ESTRADIOL 20 ug/1 - A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.
- NORETHINDRONE ACETATE 1 mg/1 - Acetate ester of norethindrone that is used as a long-term contraceptive (CONTRACEPTIVE AGENTS).
Which are Junel 21 Day UNII Codes?
The UNII codes for the active ingredients in this product are:
- NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ)
- NORETHINDRONE (UNII: T18F433X4S) (Active Moiety)
- ETHINYL ESTRADIOL (UNII: 423D2T571U)
- ETHINYL ESTRADIOL (UNII: 423D2T571U) (Active Moiety)
Which are Junel 21 Day 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:
- ACACIA (UNII: 5C5403N26O)
- SUCROSE (UNII: C151H8M554)
- MALTODEXTRIN (UNII: 7CVR7L4A2D)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- STARCH, CORN (UNII: O8232NY3SJ)
What is the NDC to RxNorm Crosswalk for Junel 21 Day?
- RxCUI: 1358762 - norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet
- RxCUI: 1358762 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet
- RxCUI: 1358762 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet
- RxCUI: 1358763 - {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack
- RxCUI: 1358763 - Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack
Which are the Pharmacologic Classes for Junel 21 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.
[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.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[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".