NDC 68180-827 Fyavolv
Norethindrone Acetate And Ethinyl Estradiol Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 68180 - Lupin Pharmaceuticals, Inc.
- 68180-827 - Fyavolv
Product Characteristics
Product Packages
NDC Code 68180-827-09
Package Description: 90 TABLET, FILM COATED in 1 BOTTLE
Price per Unit: $1.41508 per EA
NDC Code 68180-827-73
Package Description: 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK
Price per Unit: $1.41508 per EA
Product Details
What is NDC 68180-827?
What are the uses for Fyavolv?
What are Fyavolv Active Ingredients?
- ETHINYL ESTRADIOL .0025 mg/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 .5 mg/1 - Acetate ester of norethindrone that is used as a long-term contraceptive (CONTRACEPTIVE AGENTS).
Which are Fyavolv UNII Codes?
The UNII codes for the active ingredients in this product are:
- ETHINYL ESTRADIOL (UNII: 423D2T571U)
- ETHINYL ESTRADIOL (UNII: 423D2T571U) (Active Moiety)
- NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ)
- NORETHINDRONE (UNII: T18F433X4S) (Active Moiety)
Which are Fyavolv 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:
- CALCIUM STEARATE (UNII: 776XM7047L)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- STARCH, CORN (UNII: O8232NY3SJ)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TOCOPHEROL (UNII: R0ZB2556P8)
What is the NDC to RxNorm Crosswalk for Fyavolv?
- RxCUI: 1090992 - norethindrone acetate 1 MG / ethinyl estradiol 5 MCG Oral Tablet
- RxCUI: 1090992 - ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet
- RxCUI: 1090992 - ethinyl estradiol 5 MCG / norethindrone acetate 1 MG Oral Tablet
- RxCUI: 1251323 - norethindrone acetate 0.5 MG / ethinyl estradiol 2.5 MCG Oral Tablet
- RxCUI: 1251323 - ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral Tablet
Which are the Pharmacologic Classes for Fyavolv?
* 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".