CDER DATA STANDARDS MANUAL

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

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