NDC 10544-180 Fluoxetine

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
10544-180
Proprietary Name:
Fluoxetine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Blenheim Pharmacal, Inc.
Labeler Code:
10544
Start Marketing Date: [9]
01-18-2012
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329 - OPAQUE GREEN)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
E;88
Score:
1

Product Packages

NDC Code 10544-180-30

Package Description: 30 CAPSULE in 1 BOTTLE

Product Details

What is NDC 10544-180?

The NDC code 10544-180 is assigned by the FDA to the product Fluoxetine which is product labeled by Blenheim Pharmacal, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 10544-180-30 30 capsule in 1 bottle . 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 Fluoxetine?

Fluoxetine capsules, USP are indicated for the treatment of:Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)] . Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)] . Fluoxetine capsules, USP and Olanzapine in Combination are indicated for the treatment of:Acute treatment of depressive episodes associated with Bipolar I Disorder.Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.

Which are Fluoxetine UNII Codes?

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

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:

What is the NDC to RxNorm Crosswalk for Fluoxetine?

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:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".