NDC 42549-672 Escitalopram

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:
42549-672
Proprietary Name:
Escitalopram
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Stat Rx Usa Llc
Labeler Code:
42549
Start Marketing Date: [9]
03-14-2012
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
5852;20
Score:
2

Product Packages

NDC Code 42549-672-28

Package Description: 28 TABLET, FILM COATED in 1 BOTTLE

NDC Code 42549-672-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 42549-672-60

Package Description: 60 TABLET, FILM COATED in 1 BOTTLE

NDC Code 42549-672-90

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 42549-672?

The NDC code 42549-672 is assigned by the FDA to the product Escitalopram which is product labeled by Stat Rx Usa Llc. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 42549-672-28 28 tablet, film coated in 1 bottle , 42549-672-30 30 tablet, film coated in 1 bottle , 42549-672-60 60 tablet, film coated in 1 bottle , 42549-672-90 90 tablet, film coated 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 Escitalopram?

Escitalopram tablets USP is indicated for the acute and maintenance treatment of major depressive disorder in adults [see Clinical Studies (14.1)].Information related to usage of escitalopram in adolescents is approved for Forest Laboratories, Inc.'s Escitalopram Oxalate Tablets and Oral Solution. However, due to Forest Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that adolescent usage information.A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

Which are Escitalopram UNII Codes?

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

Which are Escitalopram 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 Escitalopram?

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".