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  7. Data Standards Manual (monographs): SPL Shape (Drugs)
  1. Data Standards Manual (monographs)

Data Standards Manual (monographs): SPL Shape (Drugs)

FDA Data Element Number. Pending

CDER Data Element Number. C-DRG-0929

Data Element Name. SPLSHAPE

Data Element OID: 2.16.840.1.113883.3.26.1.1.6

Data Element NCI ConceptID: C48557

Version Number: 1.0

Description. A characteristic of an oral solid dosage form of a medicinal product, specifying the two dimensional representation of the solid dose form, in terms of the outside perimeter of a solid dosage form when the dosage form, resting on a flat surface, is viewed from directly above, including slight rounding of corners. SPLSHAPE does not include embossing, scoring, debossing, or internal cut-outs. SPLSHAPE is independent of the orientation of the imprint and logo. Data values are selected from the list below. Silhouette examples of SPL SHAPEs are included, but these are only examples, and there may be other valid silhouettes.

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.
 

SPL Shapes
SPL SHAPESPL SHAPE DEFINITIONSilhouette ExampleCode
BULLETThe shape of a cylinder when viewing the capsule from a point perpendicular to its longest side, with a point at one end. The bullet shape is synonymous with torpedo shapeBullet shapeC48335
CAPSULEThe shape of a capsule when viewing the capsule from a point perpendicular to its longest side. The capsule shape is reserved for two-part capsules and banded two-part capsules. Tablets with a capsule shape or a one part capsules (e.g., soft gelatin capsules that are filled with a liquid) should be classified under OVAL.Capsule shapeC48336
CLOVERThe stylized shape, of clover, having three or four leaves with or without the stem.Clover shapeC48337
DIAMONDThe shape has four distinct sides making a parallelogram with two inner obtuse angles and two inner acute angles. A square with diagonal imprinting is not a diamond, but rather, a square. See also SQUARE.Diamond shapeC48338
DOUBLE CIRCLEThe shape of two circles joined together, and usually overlapping.Double circleC48339
FREEFORMThe shape does not have 3 or more distinct sides and is not one of the listed shapes. Examples include, but are not limited to, airplane, apple, cartoon characters, heart, kidney, shield, and train shapes. C48340
GEARThe two dimensional shape of a toothed wheel of a machine part.Gear shapeC48341
HEPTAGON (7 sided)The shape has seven distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length).Heptagon shapeC48342
HEXAGON (6 sided)The shape has six distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length).Hexagon shapeC48343
OCTAGON (8 sided)The shape has eight distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length).Octagon shapeC48344
OVALThe shape of either an oval or an ellipse. See also TEAR.Oval shapeC48345
PENTAGON (5 sided)The shape has five distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length).Pentagon shapeC48346
RECTANGLEThe shape has four distinct sides and four right angles but is not a square.Rectangle shapeC48347
ROUNDThe shape of a circle.  Spherical shapes are called round because their two dimensional projections are round.Round shapeC48348
SEMI-CIRCLEThe shape of half of a circle or half of an oval. This shape is also used for shapes similar to the letter D or the letter U. Any letter D or U that is either embossed or debossed onto the surface of a dosage form is not used in determining the shape of that dosage form.Semicircle shapeC48349
SQUAREThe shape has four distinct and equal sides with four right angles. The sides may be straight or slightly curved. A square tilted at a 45 degree angle so that the diagonals run vertical and horizontal is not a diamond, but rather, a square. See also DIAMOND.Square shapeC48350
TEARThe stylized shape of a tear or drop of water. It differs from an oval because one end is clearly larger than the other. It is synonymous with the shapes egg, pear, and almond. See also oval.Tear shapeC48351
TRAPEZOIDThe shape has four distinct sides. The sides may be straight or slightly curved. Only two of the sides are parallel.Trapezoid shapeC48352
TRIANGLEThe shape has three distinct sides. The sides may be straight or slightly curved. It can either be regular (interior angles are equal and its sides are equal in length) or irregular (interior angles are not equal and/or its sides are not equal in length).Triangle shapeC48353
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