CDER DATA STANDARDS MANUAL
FDA Data Element Number. Pending.
CDER Data Element Number. C-DRG-0931
Data Element Name. SPLIMPRINT
Version Number: 1.0
Description. A characteristic of an oral solid dosage form of a medicinal product, specifying the alphanumeric text that appears on the solid dosage form, including text that is embossed, debossed, engraved or printed with ink. The presence of other non-textual distinguishing marks or symbols is recorded by SPLSYMBOL. Excluded from SPLIMPRINT are internal and external cut-outs in the form of alphanumeric text and the letter 'R' with a circle around it (when referring to a registered trademark) and the letters 'TM' (when referring to a 'trade mark').
Examples: Included in SPLIMPRINT are alphanumeric text that appears on the bands of banded capsules and logos and other symbols that can be interpreted as letters or numbers.
Constraints: The Observation.value must be of type Character String (ST). To record text, begin on either side or part of the dosage form. Start at the top left and progress as one would normally read a book. Enter a semicolon to show separation between words or line divisions.
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.