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.
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.