Drugs

SPL Symbol

FDA Data Element Number.  Pending.

CDER Data Element Number.  C-DRG-0926

Data Element Name.  SPLSYMBOL

Version Number:  1.0

Description.  A characteristic of an oral solid dosage form of a medicinal product to describe whether or not the medicinal product has a mark or symbol appearing on it for easy and definite recognition.  Score lines, letters, numbers, and internal and external cut-outs are not considered marks or symbols. See SPLSCORING and SPLIMPRINT for these characteristics.

Constraints: The Observation.value must be a Boolean (BL) with true indicating the presence and false for the absence of marks or symbols.

Source.  SPL

Relationship.  SPL Scoring and SPL Imprint.

FDA 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.

Page Last Updated: 12/10/2014
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