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Sertraline Hydrochloride - 0378-8011-01 - (sertraline)

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Drug Information of Sertraline Hydrochloride

Product NDC: 0378-8011
Proprietary Name: Sertraline Hydrochloride
Non Proprietary Name: sertraline
Active Ingredient(s): 25    mg/1 & nbsp;   sertraline
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Sertraline Hydrochloride

Product NDC: 0378-8011
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078626
Marketing Category: ANDA
Start Marketing Date: 20130218

Package Information of Sertraline Hydrochloride

Package NDC: 0378-8011-01
Package Description: 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8011-01)

NDC Information of Sertraline Hydrochloride

NDC Code 0378-8011-01
Proprietary Name Sertraline Hydrochloride
Package Description 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8011-01)
Product NDC 0378-8011
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name sertraline
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20130218
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name SERTRALINE HYDROCHLORIDE
Strength Number 25
Strength Unit mg/1
Pharmaceutical Classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

Complete Information of Sertraline Hydrochloride


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