Route of Administration

FDA Data Element Number.  None.

CDER Data Element Number.  C-DRG-00301

Data Element Name.  Route of Administration.

Data Element OID: 2.16.840.1.113883.3.26.1.1.1
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).

Relationship. 

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.

NAME	DEFINITION	SHORT NAME	FDA CODE	NCI CONCEPT ID
AURICULAR (OTIC)	Administration to or by way of the ear.	OTIC	013	C38192
BUCCAL	Administration directed toward the cheek, generally from within the mouth.	BUCCAL	030	C38193
CONJUNCTIVAL	Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball.	CONJUNC	068	C38194
CUTANEOUS	Administration to the skin.	CUTAN	130	C38675
DENTAL	Administration to a tooth or teeth.	DENTAL	038	C38197
ELECTRO-OSMOSIS	Administration of through the diffusion of substance through a membrane in an electric field.	EL-OSMOS	357	C38633
ENDOCERVICAL	Administration within the canal of the cervix uteri.  Synonymous with the term intracervical..	E-CERVIC	131	C38205
ENDOSINUSIAL	Administration within the nasal sinuses of the head.	E-SINUS	133	C38206
ENDOTRACHEAL	Administration directly into the trachea.	E-TRACHE	401	C38208
ENTERAL	Administration directly into the intestines.	ENTER	313	C38209
EPIDURAL	Administration upon or over the dura mater.	EPIDUR	009	C38210
EXTRA‑AMNIOTIC	Administration to the outside of the membrane enveloping the fetus	X-AMNI	402	C38211
EXTRACORPOREAL	Administration outside of the body.	X-CORPOR	057	C38212
HEMODIALYSIS	Administration through hemodialysate fluid.	HEMO	140	C38200
INFILTRATION	Administration that results in substances passing into tissue spaces or into cells.	INFIL	361	C38215
INTERSTITIAL	Administration to or in the interstices of a tissue.	INTERSTIT	088	C38219
INTRA-ABDOMINAL	Administration within the abdomen.	I-ABDOM	056	C38220
INTRA-AMNIOTIC	Administration within the amnion.	I-AMNI	060	C38221
INTRA-ARTERIAL	Administration within an artery or arteries.	I-ARTER	037	C38222
INTRA-ARTICULAR	Administration within a joint.	I-ARTIC	007	C38223
INTRABILIARY	Administration within the bile, bile ducts or gallbladder.	I-BILI	362	C38224
INTRABRONCHIAL	Administration within a bronchus.	I-BRONCHI	067	C38225
INTRABURSAL	Administration within a bursa.	I-BURSAL	025	C38226
INTRACARDIAC	Administration with the heart.	I-CARDI	027	C38227
INTRACARTILAGINOUS	Administration within a cartilage; endochondral.	I-CARTIL	363	C38228
INTRACAUDAL	Administration within the cauda equina.	I-CAUDAL	413	C38229
INTRACAVERNOUS	Administration within a pathologic cavity, such as  occurs in the lung in tuberculosis.	I-CAVERN	132	C38230
INTRACAVITARY	Administration 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-CAVIT	023	C38231
INTRACEREBRAL	Administration within the cerebrum.	I-CERE	404	C38232
INTRACISTERNAL	Administration within the cisterna magna cerebellomedularis.	I-CISTERN	405	C38233
INTRACORNEAL	Administration within the cornea (the transparent structure forming the anterior part of the fibrous tunic of the eye).	I-CORNE	406	C38234
INTRACORONAL, DENTAL	Administration 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-CORONAL	117	C38217
INTRACORONARY	Administration within the coronary arteries.	I-CORONARY	119	C38218
INTRACORPORUS CAVERNOSUM	Administration within the dilatable spaces of the corporus cavernosa of the penis.	I-CORPOR	403	C38235
INTRADERMAL	Administration within the dermis.	I-DERMAL	008	C38238
INTRADISCAL	Administration within a disc.	I-DISCAL	121	C38239
INTRADUCTAL	Administration within the duct of a gland.	I-DUCTAL	123	C38240
INTRADUODENAL	Administration within the duodenum.	I-DUOD	047	C38241
INTRADURAL	Administration within or beneath the dura.	I-DURAL	052	C38242
INTRAEPIDERMAL	Administration within the epidermis.	I-EPIDERM	127	C38243
INTRAESOPHAGEAL	Administration within the esophagus.	I-ESO	072	C38245
INTRAGASTRIC	Administration within the stomach.	I-GASTRIC	046	C38246
INTRAGINGIVAL	Administration within the gingivae.	I-GINGIV	307	C38247
INTRAILEAL	Administration within the distal portion of the small intestine, from the jejunum to the cecum.	I-ILE	365	C38249
INTRALESIONAL	Administration within or introduced directly into a localized lesion.	I-LESION	042	C38250
INTRALUMINAL	Administration within the lumen of a tube.	I-LUMIN	310	C38251
INTRALYMPHATIC	Administration within the lymph.	I-LYMPHAT	352	C38252
INTRAMEDULLARY	Administration within the marrow cavity of a bone.	I-MEDUL	408	C38253
INTRAMENINGEAL	Administration within the meninges (the three membranes that envelope the brain and spinal cord).	I-MENIN	409	C38254
INTRAMUSCULAR	Administration within a muscle.	IM	005	C28161
INTRAOCULAR	Administration within the eye.	I-OCUL	036	C38255
INTRAOVARIAN	Administration within the ovary.	I-OVAR	354	C38256
INTRAPERICARDIAL	Administration within the pericardium.	I-PERICARD	314	C38257
INTRAPERITONEAL	Administration within the peritoneal cavity.	I-PERITON	004	C38258
INTRAPLEURAL	Administration within the pleura.	I-PLEURAL	043	C38259
INTRAPROSTATIC	Administration within the prostate gland.	I-PROSTAT	061	C38260
INTRAPULMONARY	Administration within the lungs or its bronchi.	I-PULMON	414	C38261
INTRASINAL	Administration within the nasal or periorbital sinuses.	I-SINAL	010	C38262
INTRASPINAL	Administration within the vertebral column.	I-SPINAL	022	C38263
INTRASYNOVIAL	Administration within the synovial cavity of a joint.	I-SYNOV	019	C38264
INTRATENDINOUS	Administration within a tendon.	I-TENDIN	049	C38265
INTRATESTICULAR	Administration within the testicle.	I-TESTIC	110	C38266
INTRATHECAL	Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.	IT	103	C38267
INTRATHORACIC	Administration within the thorax (internal to the ribs); synonymous with the term endothoracic.	I-THORAC	006	C38207
INTRATUBULAR	Administration within the tubules of an organ.	I-TUBUL	353	C38268
INTRATUMOR	Administration within a tumor.	I-TUMOR	020	C38269
INTRATYMPANIC	Administration within the aurus media.	I-TYMPAN	366	C38270
INTRAUTERINE	Administration within the uterus.	I-UTER	028	C38272
INTRAVASCULAR	Administration within a vessel or vessels.	I-VASC	021	C38273
INTRAVENOUS	Administration within or into a vein or veins.	IV	002	C38276
INTRAVENOUS BOLUS	Administration within or into a vein or veins all at once.	IV BOLUS	138	C38274
INTRAVENOUS DRIP	Administration within or into a vein or veins over a sustained period of time.	IV DRIP	137	C38279
INTRAVENTRICULAR	Administration within a ventricle.	I-VENTRIC	048	C38277
INTRAVESICAL	Administration within the bladder.	I-VESIC	128	C38278
INTRAVITREAL	Administration within the vitreous body of the eye.	I-VITRE	311	C38280
IONTOPHORESIS	Administration by means of an electric current where ions of soluble salts migrate into the tissues of the body.	ION	055	C38203
IRRIGATION	Administration to bathe or flush open wounds or body cavities.	IRRIG	032	C38281
LARYNGEAL	Administration directly upon the larynx.	LARYN	364	C38282
NASAL	Administration to the nose; administered by way of the nose.	NASAL	014	C38284
NASOGASTRIC	Administration through the nose and into the stomach, usually by means of a tube.	NG	071	C38285
NOT APPLICABLE	Routes of administration are not applicable.	NA	312	C48623
OCCLUSIVE DRESSING TECHNIQUE	Administration by the topical route which is then covered by a dressing which occludes the area.	OCCLUS	134	C38286
OPHTHALMIC	Administration  to the external eye.	OPHTHALM	012	C38287
ORAL	Administration to or by way of the mouth.	ORAL	001	C38288
OROPHARYNGEAL	Administration directly to the mouth and pharynx.	ORO	410	C38289
OTHER	Administration is different from others on this list.	OTHER	135	C38290
PARENTERAL	Administration by injection, infusion, or implantation.	PAREN	411	C38291
PERCUTANEOUS	Administration through the skin.	PERCUT	113	C38676
PERIARTICULAR	Administration around a joint.	P-ARTIC	045	C38292
PERIDURAL	Administration to the outside of the dura mater of the spinal cord..	P-DURAL	050	C38677
PERINEURAL	Administration surrounding a nerve or nerves.	P-NEURAL	412	C38293
PERIODONTAL	Administration around a tooth.	P-ODONT	040	C38294
RECTAL	Administration to the rectum.	RECTAL	016	C38295
RESPIRATORY (INHALATION)	Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.	RESPIR	136	C38216
RETROBULBAR	Administration behind the pons or behind the eyeball.	RETRO	034	C38296
SOFT TISSUE	Administration into any soft tissue.	SOFT TIS	109	C38198
SUBARACHNOID	Administration beneath the arachnoid.	S-ARACH	066	C38297
SUBCONJUNCTIVAL	Administration beneath the conjunctiva.	S-CONJUNC	096	C38298
SUBCUTANEOUS	Administration beneath the skin; hypodermic.  Synonymous with the term SUBDERMAL.	SC	003	C38299
SUBLINGUAL	Administration beneath the tongue.	SL	024	C38300
SUBMUCOSAL	Administration beneath the mucous membrane.	S-MUCOS	053	C38301
TOPICAL	Administration to a particular spot on the outer surface of the body.  The E2B term TRANSMAMMARY is a subset of the term TOPICAL.	TOPIC	011	C38304
TRANSDERMAL	Administration through the dermal layer of the skin to the systemic circulation by diffusion.	T-DERMAL	358	C38305
TRANSMUCOSAL	Administration across the mucosa.	T-MUCOS	122	C38283
TRANSPLACENTAL	Administration through or across the placenta.	T-PLACENT	415	C38307
TRANSTRACHEAL	Administration through the wall of the trachea.	T-TRACHE	355	C38308
TRANSTYMPANIC	Administration across or through the tympanic cavity.	T-TYMPAN	124	C38309
UNASSIGNED	Route of administration has not yet been assigned.	UNAS	400	C38310
UNKNOWN	Route of administration is unknown.	UNKNOWN	139	C38311
URETERAL	Administration into the ureter.	URETER	112	C38312
URETHRAL	Administration into the urethra.	URETH	017	C38271
VAGINAL	Administration into the vagina.	VAGIN	015	C38313