Sandbox dfd

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1. Basics (READ BEFORE YOU START)

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1.1 Resources

1.1.1 DailyMed

1.1.1.1 DailyMed is a public service provided by the National Library of Medicine (NLM) that encompasses FDA approved labels (package inserts) of marketed drugs.

1.1.2 Drugs@FDA

1.1.2.1 Drugs@FDA is a searchable catalog of FDA approved drug products (both prescription and over the counter) which is also useful for confirmation of the marketing status.

1.1.3 Pillbox

1.1.3.1 Pillbox is developed to aid in the identification of unknown pills (oral solid dosage form medications). It combines images of pills with appearance and other information to enable users to visually search for and identify oral solid dosage form medications.

1.1.3.2 Once a pill has been identified, additional information is provided, including brand/generic name, ingredients, and the National Drug File identification number.

1.1.3.3 Links are provided to NLM drug information resources, such as drug labels from DailyMed and the Drug Information Portal, which searches NIH and FDA drug information resources.

1.1.4 Drug Information Portal

1.1.4.1 Drug Information Portal provides links to information on breastfeeding (LactMed), drug-induced liver injury (LiverTox), manufacturers drug label (DailyMed), clinical trials (ClinicalTrials.gov), and drug Identification and Image Display (Pillbox beta).

1.1.4.2 For detailed information, it also provides links to reviewed biological and physical data (HSDB), references from scientific journals (Medline/PubMed), references from toxicological journals (TOXLINE), biological activities and chemical structures (PubChem), biological activities against HIV/AIDS and other viruses (NIAID ChemDB), toxicological and chemical resources (ChemIDplus), information from the US Food & Drug Administration (Drugs@FDA), and information from the US Drug Enforcement Administration (DEA)

1.1.5 MedlinePlus

1.1.5.1 MedlinePlus is a service of the National Library of Medicine (NLM) which contains information for drugs, herbs, and supplements.

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1.2 Generic name, active ingredient, formulation, combination, trade name, label

1.2.1 What is the generic name?

1.2.1.1 Search and confirm the generic name of the drug.

1.2.1.2 Use the generic name as the title of the landing page.

1.2.2 What is the active ingredient? Is there more than one formulation for the active ingredient?

1.2.2.1 Search and confirm the formulation(s) of the active ingredient.

1.2.2.2 If there is more than one formulation, place links (as <h3> headings) of each formulation on the top of the landing page.

1.2.3 Is the active ingredient provided as combinations with other active ingredients?

1.2.3.1 If the active ingredient is also provided as combinations with other active ingredients, place links (as <h3> headings) of each combination on the top of the landing page.

1.2.4 What is the trade name?

1.2.4.1 Search and confirm the trade names for the generic name. Please note that the trade name may be identical to the generic name in certain cases.

1.2.4.2 Search and confirm the trade names for each formulation and combination (if any). Different formulations may have identical trade names.

1.2.4.3 Include the trade names of each formulation and/or combination in parentheses.

1.2.4.4 Sort the list of formulations and/or combinations in alphabetical order.

1.2.5 Which label should be used?

1.2.5.1 Check the Marketing Start Date and the Revised date at the end of the label.

1.2.5.2 For a specific formulation of an active ingredient, use the label that is most recently updated as a reference.

1.2.6 Example

For the generic name metoprolol, there are two formulations of the active ingredient: metoprolol succinate and metoprolol tartrate.

The formulations, combinations, and trade names are as follows:

Metoprolol succinate (Toprol XL, Toprolxl XL)

Metoprolol succinate/Hydrochlorothiazide (Dutoprol)

Metoprolol tartrate (Lopressor)

Metoprolol tartrate/Arginine (Hypertensolol)

Metoprolol tartrate/Hydrochlorothiazide (Lopressor HCT)

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