NDC 42549-492 Doxepin Hydrochloride

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:
42549-492
Proprietary Name:
Doxepin Hydrochloride
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]
11-09-1987
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE OPAQUE)
BLUE (C48333 - BLUE OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
21 MM
Imprint(s):
PAR;222
Score:
1

Product Packages

NDC Code 42549-492-30

Package Description: 30 CAPSULE in 1 BOTTLE

Product Details

What is NDC 42549-492?

The NDC code 42549-492 is assigned by the FDA to the product Doxepin Hydrochloride which is product labeled by Stat Rx Usa Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 42549-492-30 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 Doxepin Hydrochloride?

Doxepin HCl is recommended for the treatment of:Psychoneurotic patients with depression and/or anxiety.Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.The target symptoms of psychoneurosis that respond particularly well to doxepin HCl include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.Clinical experience has shown that doxepin HCl is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin HCl is not recommended for use in children under 12 years of age.

Which are Doxepin Hydrochloride UNII Codes?

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

Which are Doxepin Hydrochloride 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 Doxepin Hydrochloride?

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".