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Drug Monograph
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FDA Structured Product Label
SPL (Structured Product Labeling) is the ANSI/HL7 standard for describing the content of regulated medical product labeling in XML. Drug labeling and other information in the SPL is what has been most recently submitted by drug companies to the Food and Drug Administration (FDA) as drug listing information (See 21 CFR part 207). The SPL contains information that is of primiary interest to clinicians.

Clinical Trials
Clinical Trials provides links to clinical trials at ClinicalTrials.gov that mention the drug. ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

Drug-Drug Interactions
Drug-Drug Interactions provides drug-drug interactions based on information obtained from the National Library of Medicine's Drug Interaction API. In addition to the name of the interacting drug, comments about the nature of the interaction as well as the brand names by which the interacting drug is known will be provided.

Biomedical Literature Citations
Biomedical Literature Citations are provided via PubMed. PubMed comprises more than 26 million citations for biomedical literature from MEDLINE, life science journals, and online books.

AMITRIPTYLINE HYDROCHLORIDE [AMITRIPTYLINE HYDROCHLORIDE]
Amitriptyline is used to treat symptoms of depression. Amitriptyline is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.

Dose Form: TABLET, FILM COATED

Route: ORAL

Product NDC: 16729-175

Drug Class: Tricyclic Antidepressant [EPC]

Labeler: Accord Healthcare Inc.

DEA Schedule: Unassigned

Product Type: HUMAN PRESCRIPTION DRUG

Marketing Category: Abbreviated New Drug Application (ANDA)

Physical Characteristics

Active Ingredients

• AMITRIPTYLINE HYDROCHLORIDE (100 mg)

Packaging

• 100 TABLET, FILM COATED in 1 BOTTLE (NDC: 16729-175-01)

Additional Information

• Drug Monograph 
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• Biomedical Literature Citations