NDC 13668-443 Fluoxetine
Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Product Packages
NDC Code 13668-443-10
Package Description: 1000 TABLET in 1 BOTTLE
NDC Code 13668-443-74
Package Description: 100 TABLET in 1 CARTON
Product Details
What is NDC 13668-443?
What are the uses for Fluoxetine?
What are Fluoxetine Active Ingredients?
- FLUOXETINE HYDROCHLORIDE 10 mg/1 - The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.
Which are Fluoxetine UNII Codes?
The UNII codes for the active ingredients in this product are:
- FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ)
- FLUOXETINE (UNII: 01K63SUP8D) (Active Moiety)
Which are Fluoxetine 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:
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- POVIDONE K30 (UNII: U725QWY32X)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
What is the NDC to RxNorm Crosswalk for Fluoxetine?
- RxCUI: 2532159 - FLUoxetine 10 MG Oral Tablet (PMDD)
- RxCUI: 2532159 - PMDD fluoxetine 10 MG Oral Tablet
- RxCUI: 2532163 - FLUoxetine 20 MG Oral Tablet (PMDD)
- RxCUI: 2532163 - PMDD fluoxetine 20 MG Oral Tablet
Which are the Pharmacologic Classes for Fluoxetine?
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Patient Education
Fluoxetine
Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Fluoxetine is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. It is also used along with olanzapine (Zyprexa) to treat depression that did not respond to other medications and episodes of depression in people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
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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".