DATA STANDARDS MANUAL |
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.