DATA STANDARDS MANUAL

FDA Data Element Number.  Pending.

CDER Data Element Number. 

Data Element Name.  SPLSCORE

Version Number:  1.0

Description.  A characteristic of an oral solid dosage form of a medicinal product, specifying the number of equal pieces that the solid dosage form can be divided into using score line(s).

Example: One score line creating two equal pieces is given a value of 2, two parallel score lines creating three equal pieces is given a value of 3.

Constraints: Whether three parallel score lines create four equal pieces or two intersecting score lines create two equal pieces using one score line and four equal pieces using both score lines, both have the scoring value of 4. Solid dosage forms that are not scored are given a value of 1. Solid dosage forms that can only be divided into unequal pieces are given a null-value with nullFlavor other (OTH).

Source.  SPL

Relationship.

FDA Specifications.  No further specifications.

CDER Specifications.  No further specifications.

FDA Approved Date.  30-JUN-2005

CDER Approved Date.  30-JUN-2005

FDA Revised Date. 

CDER Revised Date.

Data Values.  See constraints.

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