Drugs

Potency

FDA Data Element Number.  None.

CDER Data Element Number.  C-DRG-00501

Data Element Name.  Potency.

Data Element OID:2.16.840.1.113883.3.26.1.1.4
Data Element NCI Concept ID: C48470

Version Number.  013

Description.  This standard provides for all drug potencies and units of measure.

Only uppercase letters are to be used for the FDA code (i.e., no Greek letters, no lowercase letters substituted as Greek letters, and no symbols).  The following uppercase letters may be substituted for Greek letters: U for the Greek letter mu, which stands for MICRO.

Oftentimes, a dosage form may coexist with the actual potency term to provide clarification; when this is done, those and only those dosage form abbreviations which are presented in the table below shall be used.  Generally, an abbreviation is only made for words of greater than five characters, unless the abbreviation is a widely recognized standard (e.g., GM for GRAM). 

Whenever possible, CDER should use the metric system to express potency.  Potencies of 10-2 or less should be expressed as the next lowest value (e.g., 0.01 GM would become 10 MG), and potencies of 103 or greater should be expressed as the next highest value (e.g., 1000 MG would become 1 GM).

UCUM codes do not exist for all terms.  Some UCUM codes were deliberately omitted when their UCUM definition potentially conflicted with FDA’s position (e.g., UCUM defines a ‘drop’ as 1/12 of a milliliter).   When UCUM codes do not exist, they are sometimes ‘constructed’ from the individual components (e.g., ‘k’ for ‘kilo’ is associated with ‘g’ for ‘gram’ in order to arrive at ‘kg’ for ‘kilogram’).  When determining UCUM codes, the International System took precedence over the U.S. System which took precedence over the British System.  The Avoirdupois System took precedence over the Apothecary System.  UCUM codes are solely referenced as a convenience in order to facilitate xml coding in structured product labeling, and are not intended to be used elsewhere.

Source. COMIS Reference table (which is used by the Drug Product Reference File to generate Approved Drug Products with Therapeutic Equivalence Evaluations (aka "The Orange Book") and by the Drug Registration and Listing System).  UCUM codes are available from NIST, and at http://aurora.regenstrief.org/UCUM/

Relationship. 

FDA Specifications.  None.

CDER Specifications. Standard potency abbreviations shall consist of a maximum length restricted to 240 characters, with the virgule being only punctuation permissible in the abbreviated term itself.  Potency abbreviations shall consist of a maximum length of 6 characters with no punctuation.

FDA Approved Date.  None.

CDER Approved Date.  June 14, 1994

FDA Revised Date. 

CDER Revised Date.  October 20, 2005; January 11, 2006; February 8, 2006; March 31, 2006; April 14, 2006; May 25, 2006; July 17, 2006; August 11, 2006; August 17, 2006; September 21, 2006; July 31, 2008

Data Values. 

NAMEDEFINITIONUCUM CODEFDA CODENCI CONCEPT ID
ADJUST PHLITERAL ADJ PHC48472
AMPULELITERAL AMPULEC48473
APPLICATORLITERAL APC62412
BAGLITERAL BAGC48474
BARLITERAL BARC48475
BEADLITERAL BEADC53495
BOLUSLITERAL BOLC48476
BLISTERLITERAL BLISC54564
BLISTER PACKLITERAL BLPKC61569
BLOCKLITERAL BLOCKC53498
BOTTLELITERAL BOTC48477
BOXLITERAL BOXC48478
CANLITERAL CANC48479
CANISTERLITERAL CSTRC62413
CAPSULELITERAL CAPC48480
CAROTID SINUS RHYTHM UNITSLITERAL CSRUC48464
CARTONLITERAL CARTC54702
CARTRIDGELITERAL CTGC48481
CASELITERAL CASEC62414
CELL CULTURE INFECTIOUS DOSE 50%An expression of the result of quantifying an infectious agent in a cell culture. It is a titer, expressing the highest dilution of the specimen which produces a cytopathic effect in 50% of the cell cultures or wells inoculated.[CCID_50]CCID 50C70534
CELLO PACKLITERAL CELLOC62274
CLINICAL UNITSLITERAL CUC48482
COLONY FORMING UNITSA measurement of organism growth on supportive growth media and results recorded as CFU/ml.[CFU]CFUC68742
COATLITERAL COATC48483
COUNTLITERAL CNTC48485
CONTAINERLITERAL CTRC48484
CUBIC INCH LITERAL[in_i]3CU INC48488
CUPLITERAL CUPC54703
CURIELITERALCiCIC48466
CYLINDERLITERAL CYLC48489
DEWARLITERAL DEWC62415
DIALPACKLITERAL DLPKC62416
DISKLITERAL DISKC48490
DOSE PACKLITERAL DSPKC62417
DROPSLITERAL DROPSC48491
DRUMLITERAL DRUMC48492
FEET, CUBICLITERAL[ft_i]3CU FTC48487
FEET, SQUARELITERAL[ft_i]2SQ FTC48461
FILMLITERAL FILMC53499
FLUID DRAMLITERAL[fdr_us]FL DRC48493
FLUID OUNCELITERAL[foz_us]FL OZC48494
FOCUS-FORMING UNITSA measurement of the viral infectivity in a sensitive assay in cell culture, for example, using immunofocus or vital dyes technology.  The titer is determined by visualizing infected areas of a cell monolayer by probing with virus-specific antibodies or vital dyes and results are recorded as FFU/ml.[FFU]FFUC75303
GALLONLITERAL[gal_us]GALC48580
GENERATORLITERAL GENC48496
GRAINLITERAL[gr]GRC48497
GRAMLITERALgGMC48155
HOMEOPATHIC DILUTIONLITERAL XC48498
HOURLITERALhHOURC25529
IMPLANTLITERAL IMPC48499
INCHLITERAL[in_i]INC48500
INHALERLITERAL INHLC62275
INHALER, REFILLLITERAL INHLREC62418
INHALATIONLITERAL INHC48501
INSERTLITERAL INSERTC62276
INTERNATIONAL UNITSLITERAL[iU]IUC48579
JARLITERAL JARC48502
JUGLITERAL JUGC62419
KALLIKREIN INHIBITOR UNITLITERAL KIUC48503
KILOGRAMLITERALkgKGC28252
KITLITERAL KITC48504
LITERLITERALLLC48505
LOZENGELITERAL LOZC48506
MICROCURIELITERALuCiUCIC48507
MICROGRAMLITERALugUGMC48152
MICROLITERLITERALuLULC48153
MICROMOLELITERALumolUMOLEC48509
MICROMOLARLITERALumol/LUMOLARC48508
MICRONLITERALumMCNC48510
MILLICURIELITERALmCiMCIC48511
MILLIEQUIVALENTLITERALmeqMEQC48512
MILLIGRAMLITERALmgMGC28253
MILLILITERLITERALmLMLC28254
MILLIMETERLITERALmmMMC28251
MILLIMOLELITERALmmolMMOLEC48513
MINIMLITERAL[min_us]MINIMC48514
MISCELLANEOUSLITERAL MISCC48578
MOLARLITERALmol/LMOLARC48555
MOLELITERALmolMOLEC42539
NANOGRAMLITERALngNGMC48516
NANOMOLELITERALnmolNMOLEC48517
NORMALLITERAL NC48554
NOT APPLICABLELITERAL N/AC48587
OUNCELITERAL[oz_av]OZC48519
PACKAGELITERAL PKGC48520
PACKETLITERAL PKTC48521
PART PER MILLIONLITERAL[ppm]PPMC48523
PARTSLITERAL PARTSC48522
PATCHLITERAL PATCHC48524
PELLETLITERAL PELC48525
PERCENTLITERAL%%C48570
PERCENT VOLUME/VOLUMELITERAL %V/VC48571
PERCENT WEIGHT/VOLUMELITERAL %W/VC48527
PERCENT WEIGHT/WEIGHTLITERAL %W/WC48528
PINTLITERAL[pt_us]PTC48529
PLAQUE-FORMING UNITSAn expression of the result of quantifying an infectious agent in a sensitive assay in cell culture where the titer is determined by counting the number of
visible plaques developed following viral infection of a sensitive
cell culture and results recorded as PFU/ml.
[PFU]PFUC67264
POTENCY NOT GIVENLITERAL PNGC48588
POUCHLITERAL POUCHC48530
POUNDLITERAL[lb_av]LBC48531
PRESSOR UNITSLITERAL PRUC48532
PROTEIN UNITLITERAL PNUC48533
QUANTITY SUFFICIENTLITERAL QSC48590
QUARTLITERAL[qt_us]QTC48534
RINGLITERAL RINGC62609
SATURATEDLITERAL SATC48535
SCOOPFULLITERAL SCPC48536
SPONGELITERAL SPONGEC53502
SPRAYLITERAL SPRAYC48537
SQUARE CENTIMETERLITERALcm2SQ CMC48460
SQUARE YARDLITERAL[yd_i]2SQ YDC48462
STICKLITERAL STICKC53503
STRIPLITERAL STRIPC48538
SUPERSACKLITERAL SUPSACKC62420
SUPPOSITORYLITERAL SUPPC48539
SWABLITERAL SWABC53504
SYRINGELITERAL SYRC48540
TABLETLITERAL TABC48542
TABLESPOONLITERAL[tbs_us]TBSPC48541
TABMINDERLITERAL TABMINDC62421
TAMPONLITERAL TAMPC48543
TANKLITERAL TANKC62422
TEASPOONLITERAL[tsp_us]TSPC48544
TESTLITERAL TESTC48545
TISSUE CULTURE INFECTIOUS DOSE 50%An expression of the result of quantifying an infectious agent in tissue culture. It is a titer, expressing the highest dilution of the specimen which produces a cytopathic effect in 50% of the cell cultures or wells inoculated.[TCID_50]TCID 50C67450
TRAYLITERAL TRAYC54704
TONLITERAL TONC48546
TRACELITERAL TRACEC48547
TROCHELITERAL TROC48548
TUBELITERAL TUBEC48549
UNASSIGNEDLITERAL U/AC48591
UNITED STATES PHARMACOPEIA UNITLITERAL[USP'U]USP UNITC48469
UNITSLITERAL UNITSC44278
VIALLITERAL VIALC48551
WAFERLITERAL WAFERC48552
YARDLITERAL[yd_i]YDC48553

 

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