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. 

NAME	DEFINITION	UCUM CODE	FDA CODE	NCI CONCEPT ID
ADJUST PH	LITERAL		ADJ PH	C48472
AMPULE	LITERAL		AMPULE	C48473
APPLICATOR	LITERAL		AP	C62412
BAG	LITERAL		BAG	C48474
BAR	LITERAL		BAR	C48475
BEAD	LITERAL		BEAD	C53495
BOLUS	LITERAL		BOL	C48476
BLISTER	LITERAL		BLIS	C54564
BLISTER PACK	LITERAL		BLPK	C61569
BLOCK	LITERAL		BLOCK	C53498
BOTTLE	LITERAL		BOT	C48477
BOX	LITERAL		BOX	C48478
CAN	LITERAL		CAN	C48479
CANISTER	LITERAL		CSTR	C62413
CAPSULE	LITERAL		CAP	C48480
CAROTID SINUS RHYTHM UNITS	LITERAL		CSRU	C48464
CARTON	LITERAL		CART	C54702
CARTRIDGE	LITERAL		CTG	C48481
CASE	LITERAL		CASE	C62414
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 50	C70534
CELLO PACK	LITERAL		CELLO	C62274
CLINICAL UNITS	LITERAL		CU	C48482
COLONY FORMING UNITS	A measurement of organism growth on supportive growth media and results recorded as CFU/ml.	[CFU]	CFU	C68742
COAT	LITERAL		COAT	C48483
COUNT	LITERAL		CNT	C48485
CONTAINER	LITERAL		CTR	C48484
CUBIC INCH	LITERAL	[in_i]3	CU IN	C48488
CUP	LITERAL		CUP	C54703
CURIE	LITERAL	Ci	CI	C48466
CYLINDER	LITERAL		CYL	C48489
DEWAR	LITERAL		DEW	C62415
DIALPACK	LITERAL		DLPK	C62416
DISK	LITERAL		DISK	C48490
DOSE PACK	LITERAL		DSPK	C62417
DROPS	LITERAL		DROPS	C48491
DRUM	LITERAL		DRUM	C48492
FEET, CUBIC	LITERAL	[ft_i]3	CU FT	C48487
FEET, SQUARE	LITERAL	[ft_i]2	SQ FT	C48461
FILM	LITERAL		FILM	C53499
FLUID DRAM	LITERAL	[fdr_us]	FL DR	C48493
FLUID OUNCE	LITERAL	[foz_us]	FL OZ	C48494
FOCUS-FORMING UNITS	A 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]	FFU	C75303
GALLON	LITERAL	[gal_us]	GAL	C48580
GENERATOR	LITERAL		GEN	C48496
GRAIN	LITERAL	[gr]	GR	C48497
GRAM	LITERAL	g	GM	C48155
HOMEOPATHIC DILUTION	LITERAL		X	C48498
HOUR	LITERAL	h	HOUR	C25529
IMPLANT	LITERAL		IMP	C48499
INCH	LITERAL	[in_i]	IN	C48500
INHALER	LITERAL		INHL	C62275
INHALER, REFILL	LITERAL		INHLRE	C62418
INHALATION	LITERAL		INH	C48501
INSERT	LITERAL		INSERT	C62276
INTERNATIONAL UNITS	LITERAL	[iU]	IU	C48579
JAR	LITERAL		JAR	C48502
JUG	LITERAL		JUG	C62419
KALLIKREIN INHIBITOR UNIT	LITERAL		KIU	C48503
KILOGRAM	LITERAL	kg	KG	C28252
KIT	LITERAL		KIT	C48504
LITER	LITERAL	L	L	C48505
LOZENGE	LITERAL		LOZ	C48506
MICROCURIE	LITERAL	uCi	UCI	C48507
MICROGRAM	LITERAL	ug	UGM	C48152
MICROLITER	LITERAL	uL	UL	C48153
MICROMOLE	LITERAL	umol	UMOLE	C48509
MICROMOLAR	LITERAL	umol/L	UMOLAR	C48508
MICRON	LITERAL	um	MCN	C48510
MILLICURIE	LITERAL	mCi	MCI	C48511
MILLIEQUIVALENT	LITERAL	meq	MEQ	C48512
MILLIGRAM	LITERAL	mg	MG	C28253
MILLILITER	LITERAL	mL	ML	C28254
MILLIMETER	LITERAL	mm	MM	C28251
MILLIMOLE	LITERAL	mmol	MMOLE	C48513
MINIM	LITERAL	[min_us]	MINIM	C48514
MISCELLANEOUS	LITERAL		MISC	C48578
MOLAR	LITERAL	mol/L	MOLAR	C48555
MOLE	LITERAL	mol	MOLE	C42539
NANOGRAM	LITERAL	ng	NGM	C48516
NANOMOLE	LITERAL	nmol	NMOLE	C48517
NORMAL	LITERAL		N	C48554
NOT APPLICABLE	LITERAL		N/A	C48587
OUNCE	LITERAL	[oz_av]	OZ	C48519
PACKAGE	LITERAL		PKG	C48520
PACKET	LITERAL		PKT	C48521
PART PER MILLION	LITERAL	[ppm]	PPM	C48523
PARTS	LITERAL		PARTS	C48522
PATCH	LITERAL		PATCH	C48524
PELLET	LITERAL		PEL	C48525
PERCENT	LITERAL	%	%	C48570
PERCENT VOLUME/VOLUME	LITERAL		%V/V	C48571
PERCENT WEIGHT/VOLUME	LITERAL		%W/V	C48527
PERCENT WEIGHT/WEIGHT	LITERAL		%W/W	C48528
PINT	LITERAL	[pt_us]	PT	C48529
PLAQUE-FORMING UNITS	An 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]	PFU	C67264
POTENCY NOT GIVEN	LITERAL		PNG	C48588
POUCH	LITERAL		POUCH	C48530
POUND	LITERAL	[lb_av]	LB	C48531
PRESSOR UNITS	LITERAL		PRU	C48532
PROTEIN UNIT	LITERAL		PNU	C48533
QUANTITY SUFFICIENT	LITERAL		QS	C48590
QUART	LITERAL	[qt_us]	QT	C48534
RING	LITERAL		RING	C62609
SATURATED	LITERAL		SAT	C48535
SCOOPFUL	LITERAL		SCP	C48536
SPONGE	LITERAL		SPONGE	C53502
SPRAY	LITERAL		SPRAY	C48537
SQUARE CENTIMETER	LITERAL	cm2	SQ CM	C48460
SQUARE YARD	LITERAL	[yd_i]2	SQ YD	C48462
STICK	LITERAL		STICK	C53503
STRIP	LITERAL		STRIP	C48538
SUPERSACK	LITERAL		SUPSACK	C62420
SUPPOSITORY	LITERAL		SUPP	C48539
SWAB	LITERAL		SWAB	C53504
SYRINGE	LITERAL		SYR	C48540
TABLET	LITERAL		TAB	C48542
TABLESPOON	LITERAL	[tbs_us]	TBSP	C48541
TABMINDER	LITERAL		TABMIND	C62421
TAMPON	LITERAL		TAMP	C48543
TANK	LITERAL		TANK	C62422
TEASPOON	LITERAL	[tsp_us]	TSP	C48544
TEST	LITERAL		TEST	C48545
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 50	C67450
TRAY	LITERAL		TRAY	C54704
TON	LITERAL		TON	C48546
TRACE	LITERAL		TRACE	C48547
TROCHE	LITERAL		TRO	C48548
TUBE	LITERAL		TUBE	C48549
UNASSIGNED	LITERAL		U/A	C48591
UNITED STATES PHARMACOPEIA UNIT	LITERAL	[USP'U]	USP UNIT	C48469
UNITS	LITERAL		UNITS	C44278
VIAL	LITERAL		VIAL	C48551
WAFER	LITERAL		WAFER	C48552
YARD	LITERAL	[yd_i]	YD	C48553