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U.S. Department of Health and Human Services

Drugs

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SPL Size

FDA Data Element Number.  Pending.

CDER Data Element Number.  C-DRG-0928

Data Element Name.  SPLSIZE

Version Number:  1.0

Description.  A characteristic of an oral solid dosage form of a medicinal product, specifying the longest single dimension of the solid dosage form as a physical quantity in the dimension of length (e.g., 3 mm).

Example: SPLSIZE for a rectangular shaped tablet is the length and SPLSIZE for a round shaped tablet is the diameter.

Constraints: The length is always in millimeters and should be rounded to the nearest whole millimeter.

Source.  SPL

Relationship.

FDA Specifications.  No further specifications.

CDER Specifications.  No further specifications.

FDA Approved Date.  25-MAY-2005

CDER Approved Date.  25-MAY-2005

FDA Revised Date. 

CDER Revised Date.

Data Values.  See constraints.