NDC 50436-0013 Sertraline 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:
50436-0013
Proprietary Name:
Sertraline Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Unit Dose Services
Labeler Code:
50436
Start Marketing Date: [9]
02-06-2007
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329)
BLUE (C48333)
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
7 MM
10 MM
13 MM
Imprint(s):
A;1;6
A;1;7
A;1;8
Score:
2

Product Packages

NDC Code 50436-0013-1

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 50436-0013-3

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 50436-0013?

The NDC code 50436-0013 is assigned by the FDA to the product Sertraline Hydrochloride which is product labeled by Unit Dose Services. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 50436-0013-1 30 tablet, film coated in 1 bottle , 50436-0013-3 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 Sertraline Hydrochloride?

Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]:Major depressive disorder (MDD)Obsessive-compulsive disorder (OCD)Panic disorder (PD)Posttraumatic stress disorder (PTSD)Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD)

Which are Sertraline Hydrochloride UNII Codes?

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

Which are Sertraline 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 Sertraline 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".