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  7. Route of Administration
  1. Data Standards Manual (monographs)

Route of Administration

FDA Data Element Number.  None.

CDER Data Element Number.  C-DRG-00301

Data Element Name.  Route of Administration.

Data Element OID: 2.16.840.1.113883.
Data Element NCI Concept ID: C38114

Version Number.  004

Description.  This standard provides for all routes of administration for drugs. 

Source.  COMIS Reference table (which is used by the Drug Product Reference File to generate Approved Drug Products with Therapeutic Equivalence Evaluations (a.k.a. "The Orange Book")), and the Drug Registration and Listing Database, Office of Epidemiology and Biosurveillance Database.  Also, the names (but not the definitions or the numeric codes) that are represented in blue have been harmonized with the E2B route of administration terms for the International Conference on Harmonization (ICH).


FDA Specifications.  None.

CDER Specifications.  Route of Administration shall consist of an alphabetic term which has a maximum length shall be restricted to 60 characters, with the hyphen and virgule being only punctuation permissible.  Codes representing these Routes of Administration shall consist of three digits.  In addition, since the prefixes intra- and endo- both mean within, the NSC generally felt that most US clinicians prefer the intra- prefix rather than the endo- prefix for route terms, with some exceptions (e.g., endotracheal).  Some general terms (e.g., parenteral) should be reserved for instances when a particular route of administration is unknown (e.g., MedWatch forms).  When possible E2B terms should take precedence.

FDA Approved Date.  None.

CDER Approved Date.  April 14, 1992

FDA Revised Date. 

CDER Revised Dates.  November 10, 1992;  October 11, 1994;  November 8, 1996;  January 29, 1997;  April 21, 1997; November 14, 1997; December 21, 2000; October 20, 2005; January 11, 2006

Data Values.

AURICULAR (OTIC)Administration to or by way of the ear.OTIC013C38192
BUCCALAdministration directed toward the cheek, generally from within the mouth.BUCCAL030C38193
CONJUNCTIVALAdministration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball.CONJUNC068C38194
CUTANEOUSAdministration to the skin.CUTAN130C38675
DENTALAdministration to a tooth or teeth.DENTAL038C38197
ELECTRO-OSMOSISAdministration of through the diffusion of substance through a membrane in an electric field.EL-OSMOS357C38633
ENDOCERVICALAdministration within the canal of the cervix uteri.  Synonymous with the term intracervical..E-CERVIC131C38205
ENDOSINUSIALAdministration within the nasal sinuses of the head.E-SINUS133C38206
ENDOTRACHEALAdministration directly into the trachea.E-TRACHE401C38208
ENTERALAdministration directly into the intestines.ENTER313C38209
EPIDURALAdministration upon or over the dura mater.EPIDUR009C38210
EXTRA‑AMNIOTICAdministration to the outside of the membrane enveloping the fetusX-AMNI402C38211
EXTRACORPOREALAdministration outside of the body.X-CORPOR057C38212
HEMODIALYSISAdministration through hemodialysate fluid.HEMO140C38200
INFILTRATIONAdministration that results in substances passing into tissue spaces or into cells.INFIL361C38215
INTERSTITIALAdministration to or in the interstices of a tissue.INTERSTIT088C38219
INTRA-ABDOMINALAdministration within the abdomen.I-ABDOM056C38220
INTRA-AMNIOTICAdministration within the amnion.I-AMNI060C38221
INTRA-ARTERIALAdministration within an artery or arteries.I-ARTER037C38222
INTRA-ARTICULARAdministration within a joint.I-ARTIC007C38223
INTRABILIARYAdministration within the bile, bile ducts or gallbladder.I-BILI362C38224
INTRABRONCHIALAdministration within a bronchus.I-BRONCHI067C38225
INTRABURSALAdministration within a bursa.I-BURSAL025C38226
INTRACARDIACAdministration with the heart.I-CARDI027C38227
INTRACARTILAGINOUSAdministration within a cartilage; endochondral.I-CARTIL363C38228
INTRACAUDALAdministration within the cauda equina.I-CAUDAL413C38229
INTRACAVERNOUSAdministration within a pathologic cavity, such as  occurs in the lung in tuberculosis.I-CAVERN132C38230
INTRACAVITARYAdministration within a non-pathologic cavity, such as that of the cervix, uterus, or penis, or such as that which is formed as the result of a wound.I-CAVIT023C38231
INTRACEREBRALAdministration within the cerebrum.I-CERE404C38232
INTRACISTERNALAdministration within the cisterna magna cerebellomedularis.I-CISTERN405C38233
INTRACORNEALAdministration within the cornea (the transparent structure forming the anterior part of the fibrous tunic of the eye).I-CORNE406C38234
INTRACORONAL, DENTALAdministration of a drug within a portion of a tooth which is covered by enamel and which is separated from the roots by a slightly constricted region known as the neck.I-CORONAL117C38217
INTRACORONARYAdministration within the coronary arteries.I-CORONARY119C38218
INTRACORPORUS CAVERNOSUMAdministration within the dilatable spaces of the corporus cavernosa of the penis.I-CORPOR403C38235
INTRADERMALAdministration within the dermis.I-DERMAL008C38238
INTRADISCALAdministration within a disc.I-DISCAL121C38239
INTRADUCTALAdministration within the duct of a gland.I-DUCTAL123C38240
INTRADUODENALAdministration within the duodenum.I-DUOD047C38241
INTRADURALAdministration within or beneath the dura.I-DURAL052C38242
INTRAEPIDERMALAdministration within the epidermis.I-EPIDERM127C38243
INTRAESOPHAGEALAdministration within the esophagus.I-ESO072C38245
INTRAGASTRICAdministration within the stomach.I-GASTRIC046C38246
INTRAGINGIVALAdministration within the gingivae.I-GINGIV307C38247
INTRAILEALAdministration within the distal portion of the small intestine, from the jejunum to the cecum.I-ILE365C38249
INTRALESIONALAdministration within or introduced directly into a localized lesion.I-LESION042C38250
INTRALUMINALAdministration within the lumen of a tube.I-LUMIN310C38251
INTRALYMPHATICAdministration within the lymph.I-LYMPHAT352C38252
INTRAMEDULLARYAdministration within the marrow cavity of a bone.I-MEDUL408C38253
INTRAMENINGEALAdministration within the meninges (the three membranes that envelope the brain and spinal cord).I-MENIN409C38254
INTRAMUSCULARAdministration within a muscle.IM005C28161
INTRAOCULARAdministration within the eye.I-OCUL036C38255
INTRAOVARIANAdministration within the ovary.I-OVAR354C38256
INTRAPERICARDIALAdministration within the pericardium.I-PERICARD314C38257
INTRAPERITONEALAdministration within the peritoneal cavity.I-PERITON004C38258
INTRAPLEURALAdministration within the pleura.I-PLEURAL043C38259
INTRAPROSTATICAdministration within the prostate gland.I-PROSTAT061C38260
INTRAPULMONARYAdministration within the lungs or its bronchi.I-PULMON414C38261
INTRASINALAdministration within the nasal or periorbital sinuses.I-SINAL010C38262
INTRASPINALAdministration within the vertebral column.I-SPINAL022C38263
INTRASYNOVIALAdministration within the synovial cavity of a joint.I-SYNOV019C38264
INTRATENDINOUSAdministration within a tendon.I-TENDIN049C38265
INTRATESTICULARAdministration within the testicle.I-TESTIC110C38266
INTRATHECALAdministration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.IT103C38267
INTRATHORACICAdministration within the thorax (internal to the ribs); synonymous with the term endothoracic.I-THORAC006C38207
INTRATUBULARAdministration within the tubules of an organ.I-TUBUL353C38268
INTRATUMORAdministration within a tumor.I-TUMOR020C38269
INTRATYMPANICAdministration within the aurus media.I-TYMPAN366C38270
INTRAUTERINEAdministration within the uterus.I-UTER028C38272
INTRAVASCULARAdministration within a vessel or vessels.I-VASC021C38273
INTRAVENOUSAdministration within or into a vein or veins.IV002C38276
INTRAVENOUS BOLUSAdministration within or into a vein or veins all at once.IV BOLUS138C38274
INTRAVENOUS DRIPAdministration within or into a vein or veins over a sustained period of time.IV DRIP137C38279
INTRAVENTRICULARAdministration within a ventricle.I-VENTRIC048C38277
INTRAVESICALAdministration within the bladder.I-VESIC128C38278
INTRAVITREALAdministration within the vitreous body of the eye.I-VITRE311C38280
IONTOPHORESISAdministration by means of an electric current where ions of soluble salts migrate into the tissues of the body.ION055C38203
IRRIGATIONAdministration to bathe or flush open wounds or body cavities.IRRIG032C38281
LARYNGEALAdministration directly upon the larynx.LARYN364C38282
NASALAdministration to the nose; administered by way of the nose.NASAL014C38284
NASOGASTRICAdministration through the nose and into the stomach, usually by means of a tube.NG071C38285
NOT APPLICABLERoutes of administration are not applicable.NA312C48623
OCCLUSIVE DRESSING TECHNIQUEAdministration by the topical route which is then covered by a dressing which occludes the area.OCCLUS134C38286
OPHTHALMICAdministration  to the external eye.OPHTHALM012C38287
ORALAdministration to or by way of the mouth.ORAL001C38288
OROPHARYNGEALAdministration directly to the mouth and pharynx.ORO410C38289
OTHERAdministration is different from others on this list.OTHER135C38290
PARENTERALAdministration by injection, infusion, or implantation.PAREN411C38291
PERCUTANEOUSAdministration through the skin.PERCUT113C38676
PERIARTICULARAdministration around a joint.P-ARTIC045C38292
PERIDURALAdministration to the outside of the dura mater of the spinal cord..P-DURAL050C38677
PERINEURALAdministration surrounding a nerve or nerves.P-NEURAL412C38293
PERIODONTALAdministration around a tooth.P-ODONT040C38294
RECTALAdministration to the rectum.RECTAL016C38295
RESPIRATORY (INHALATION)Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.RESPIR136C38216
RETROBULBARAdministration behind the pons or behind the eyeball.RETRO034C38296
SOFT TISSUEAdministration into any soft tissue.SOFT TIS109C38198
SUBARACHNOIDAdministration beneath the arachnoid.S-ARACH066C38297
SUBCONJUNCTIVALAdministration beneath the conjunctiva.S-CONJUNC096C38298
SUBCUTANEOUSAdministration beneath the skin; hypodermic.  Synonymous with the term SUBDERMAL.SC003C38299
SUBLINGUALAdministration beneath the tongue.SL024C38300
SUBMUCOSALAdministration beneath the mucous membrane.S-MUCOS053C38301
TOPICALAdministration to a particular spot on the outer surface of the body.  The E2B term TRANSMAMMARY is a subset of the term TOPICAL.TOPIC011C38304
TRANSDERMALAdministration through the dermal layer of the skin to the systemic circulation by diffusion.T-DERMAL358C38305
TRANSMUCOSALAdministration across the mucosa.T-MUCOS122C38283
TRANSPLACENTALAdministration through or across the placenta.T-PLACENT415C38307
TRANSTRACHEALAdministration through the wall of the trachea.T-TRACHE355C38308
TRANSTYMPANICAdministration across or through the tympanic cavity.T-TYMPAN124C38309
UNASSIGNEDRoute of administration has not yet been assigned.UNAS400C38310
UNKNOWNRoute of administration is unknown.UNKNOWN139C38311
URETERALAdministration into the ureter.URETER112C38312
URETHRALAdministration into the urethra.URETH017C38271
VAGINALAdministration into the vagina.VAGIN015C38313
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