NDC 66993-002 Estradiol Vaginal Cream
Estradiol Cream Vaginal - View Dosage, Usage, Ingredients, Routes, UNII
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Product Details
What is NDC 66993-002?
What are the uses for Estradiol Vaginal Cream?
What are Estradiol Vaginal Cream Active Ingredients?
- ESTRADIOL .1 mg/g - The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.
Which are Estradiol Vaginal Cream UNII Codes?
The UNII codes for the active ingredients in this product are:
- ESTRADIOL (UNII: 4TI98Z838E)
- ESTRADIOL (UNII: 4TI98Z838E) (Active Moiety)
Which are Estradiol Vaginal Cream 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:
- WATER (UNII: 059QF0KO0R)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
- CERESIN (UNII: Q1LS2UJO3A)
- CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)
- HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- EDETATE DISODIUM (UNII: 7FLD91C86K)
- TERT-BUTYLHYDROQUINONE (UNII: C12674942B)
What is the NDC to RxNorm Crosswalk for Estradiol Vaginal Cream?
- RxCUI: 310169 - estradiol 0.01 % Vaginal Cream
- RxCUI: 310169 - estradiol 0.1 MG/ML Vaginal Cream
Which are the Pharmacologic Classes for Estradiol Vaginal Cream?
* Please review the disclaimer below.
Patient Education
Estradiol Topical
Estradiol topical gel and emulsion (lotion type mixture) are used to treat and prevent hot flushes (hot flashes; sudden strong feelings of heat and sweating) in women who are experiencing menopause (change of life; the end of monthly menstrual periods). Estradiol topical gel is also used to treat vaginal dryness, itching, and burning in women who are experiencing menopause. However, women whose only bothersome symptoms are vaginal burning, itching, and dryness may benefit more from a medication that is applied topically to the vagina. Estradiol is in a class of medications called estrogen hormones. It works by replacing estrogen that is normally produced by the body.
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Estrogen Vaginal
Vaginal estrogen is used to treat vaginal dryness, itching, and burning; painful or difficult urination; and sudden need to urinate immediately in women who are experiencing or have experienced menopause (change of life; the end of monthly menstrual periods). Femring® brand vaginal ring is also used to treat hot flushes ('hot flashes'; sudden strong feelings of heat and sweating) in women who are experiencing menopause. Premarin® brand vaginal cream is also used to treat kraurosis vulvae (a condition that may cause vaginal dryness and discomfort in women or girls of any age). Imvexxy® brand vaginal inserts are used for the treatment of dyspareunia (difficult or painful sexual intercourse) in menopausal women. Vaginal estrogen is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
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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".