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 AURICULAR (OTIC) BUCCAL CONJUNCTIVAL

DEFINITION Administration to or by way of the ear. Administration directed toward the cheek, generally from within the mouth. Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball. Administration to the skin. Administration to a tooth or teeth. Administration of through the diffusion of substance through a membrane in an electric field. Administration within the canal of the cervix uteri. Synonymous with the term intracervical.. Administration within the nasal sinuses of the head. Administration directly into the trachea. Administration directly into the intestines. Administration upon or over the dura mater.

SHORT NAME OTIC BUCCAL CONJUNC

FDA CODE 013 030 068

NCI CONCEPT ID C38192 C38193 C38194

CUTANEOUS DENTAL ELECTRO-OSMOSIS ENDOCERVICAL ENDOSINUSIAL ENDOTRACHEAL ENTERAL EPIDURAL

CUTAN DENTAL EL-OSMOS E-CERVIC E-SINUS E-TRACHE ENTER EPIDUR

130 038 357 131 133 401 313 009

C38675 C38197 C38633 C38205 C38206 C38208 C38209 C38210

EXTRA-AMNIOTIC EXTRACORPOREAL HEMODIALYSIS INFILTRATION INTERSTITIAL INTRA-ABDOMINAL INTRA-AMNIOTIC INTRA-ARTERIAL INTRA-ARTICULAR INTRABILIARY INTRABRONCHIAL INTRABURSAL INTRACARDIAC INTRACARTILAGINOUS INTRACAUDAL INTRACAVERNOUS INTRACAVITARY

Administration to the outside of the membrane enveloping the fetus Administration outside of the body. Administration through hemodialysate fluid. Administration that results in substances passing into tissue spaces or into cells. Administration to or in the interstices of a tissue. Administration within the abdomen. Administration within the amnion. Administration within an artery or arteries. Administration within a joint.

X-AMNI X-CORPOR HEMO INFIL INTERSTIT I-ABDOM I-AMNI I-ARTER I-ARTIC

402 057 140 361 088 056 060 037 007 362 067 025 027 363 413 132 023

C38211 C38212 C38200 C38215 C38219 C38220 C38221 C38222 C38223 C38224 C38225 C38226 C38227 C38228 C38229 C38230 C38231

Administration within the bile, bile ducts or gallbladder. I-BILI Administration within a bronchus. Administration within a bursa. Administration with the heart. Administration within a cartilage; endochondral. Administration within the cauda equina. Administration within a pathologic cavity, such as occurs in the lung in tuberculosis. 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. Administration within the cerebrum. Administration within the cisterna magna cerebellomedularis. Administration within the cornea (the transparent structure forming the anterior part of the fibrous tunic of the eye). 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. Administration within the coronary arteries. Administration within the dilatable spaces of the corporus cavernosa of the penis. Administration within the dermis. Administration within a disc. Administration within the duct of a gland. Administration within the duodenum. Administration within or beneath the dura. Administration within the epidermis. Administration within the esophagus. Administration within the stomach. Administration within the gingivae. Administration within the distal portion of the small intestine, from the jejunum to the cecum. Administration within or introduced directly into a localized lesion. I-BRONCHI I-BURSAL I-CARDI I-CARTIL I-CAUDAL I-CAVERN I-CAVIT

INTRACEREBRAL INTRACISTERNAL INTRACORNEAL

I-CERE I-CISTERN I-CORNE

404 405 406

C38232 C38233 C38234

INTRACORONAL, DENTAL

I-CORONAL

117

C38217

INTRACORONARY INTRACORPORUS CAVERNOSUM INTRADERMAL INTRADISCAL INTRADUCTAL INTRADUODENAL INTRADURAL INTRAEPIDERMAL INTRAESOPHAGEAL INTRAGASTRIC INTRAGINGIVAL INTRAILEAL INTRALESIONAL

I-CORONARY I-CORPOR I-DERMAL I-DISCAL I-DUCTAL I-DUOD I-DURAL I-EPIDERM I-ESO I-GASTRIC I-GINGIV I-ILE I-LESION

119 403 008 121 123 047 052 127 072 046 307 365 042

C38218 C38235 C38238 C38239 C38240 C38241 C38242 C38243 C38245 C38246 C38247 C38249 C38250

INTRALUMINAL INTRALYMPHATIC INTRAMEDULLARY INTRAMENINGEAL INTRAMUSCULAR INTRAOCULAR INTRAOVARIAN INTRAPERICARDIAL INTRAPERITONEAL INTRAPLEURAL INTRAPROSTATIC INTRAPULMONARY INTRASINAL INTRASPINAL INTRASYNOVIAL INTRATENDINOUS INTRATESTICULAR INTRATHECAL

Administration within the lumen of a tube. Administration within the lymph. Administration within the marrow cavity of a bone. Administration within the meninges (the three membranes that envelope the brain and spinal cord). Administration within a muscle. Administration within the eye. Administration within the ovary. Administration within the pericardium. Administration within the peritoneal cavity. Administration within the pleura. Administration within the prostate gland. Administration within the lungs or its bronchi. Administration within the nasal or periorbital sinuses. Administration within the vertebral column. Administration within the synovial cavity of a joint. Administration within a tendon. Administration within the testicle. Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles. Administration within the thorax (internal to the ribs); synonymous with the term endothoracic. Administration within the tubules of an organ. Administration within a tumor. Administration within the aurus media. Administration within the uterus. Administration within a vessel or vessels. Administration within or into a vein or veins.

I-LUMIN I-LYMPHAT I-MEDUL I-MENIN IM I-OCUL I-OVAR I-PERICARD I-PERITON I-PLEURAL I-PROSTAT I-PULMON I-SINAL I-SPINAL I-SYNOV I-TENDIN I-TESTIC IT

310 352 408 409 005 036 354 314 004 043 061 414 010 022 019 049 110 103

C38251 C38252 C38253 C38254 C28161 C38255 C38256 C38257 C38258 C38259 C38260 C38261 C38262 C38263 C38264 C38265 C38266 C38267

INTRATHORACIC INTRATUBULAR INTRATUMOR INTRATYMPANIC INTRAUTERINE INTRAVASCULAR INTRAVENOUS INTRAVENOUS BOLUS INTRAVENOUS DRIP INTRAVENTRICULAR INTRAVESICAL INTRAVITREAL IONTOPHORESIS IRRIGATION LARYNGEAL NASAL NASOGASTRIC NOT APPLICABLE OCCLUSIVE DRESSING TECHNIQUE

I-THORAC I-TUBUL I-TUMOR I-TYMPAN I-UTER I-VASC IV

006 353 020 366 028 021 002 138 137 048 128 311 055 032 364 014 071 312 134

C38207 C38268 C38269 C38270 C38272 C38273 C38276 C38274 C38279 C38277 C38278 C38280 C38203 C38281 C38282 C38284 C38285 C48623 C38286

Administration within or into a vein or veins all at once. IV BOLUS Administration within or into a vein or veins over a sustained period of time. Administration within a ventricle. Administration within the bladder. Administration within the vitreous body of the eye. IV DRIP I-VENTRIC I-VESIC I-VITRE

Administration by means of an electric current where ION ions of soluble salts migrate into the tissues of the body. Administration to bathe or flush open wounds or body cavities. Administration directly upon the larynx. Administration to the nose; administered by way of the nose. Administration through the nose and into the stomach, usually by means of a tube. Routes of administration are not applicable. Administration by the topical route which is then IRRIG LARYN NASAL NG NA OCCLUS

covered by a dressing which occludes the area. OPHTHALMIC ORAL OROPHARYNGEAL OTHER PARENTERAL PERCUTANEOUS PERIARTICULAR PERIDURAL PERINEURAL PERIODONTAL RECTAL RESPIRATORY (INHALATION) RETROBULBAR SOFT TISSUE SUBARACHNOID SUBCONJUNCTIVAL SUBCUTANEOUS SUBLINGUAL SUBMUCOSAL TOPICAL Administration to the external eye. Administration to or by way of the mouth. Administration directly to the mouth and pharynx. Administration is different from others on this list. Administration by injection, infusion, or implantation. Administration through the skin. Administration around a joint. Administration to the outside of the dura mater of the spinal cord.. Administration surrounding a nerve or nerves. Administration around a tooth. Administration to the rectum. Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. Administration behind the pons or behind the eyeball. Administration into any soft tissue. Administration beneath the arachnoid. Administration beneath the conjunctiva. Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. Administration beneath the tongue. Administration beneath the mucous membrane. Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. Administration through the dermal layer of the skin to the systemic circulation by diffusion. Administration across the mucosa. Administration through or across the placenta. Administration through the wall of the trachea. Administration across or through the tympanic cavity. Route of administration has not yet been assigned. Route of administration is unknown. Administration into the ureter. Administration into the urethra. Administration into the vagina. OPHTHALM ORAL ORO OTHER PAREN PERCUT P-ARTIC P-DURAL P-NEURAL P-ODONT RECTAL RESPIR RETRO SOFT TIS S-ARACH S-CONJUNC SC SL S-MUCOS TOPIC 012 001 410 135 411 113 045 050 412 040 016 136 034 109 066 096 003 024 053 011 C38287 C38288 C38289 C38290 C38291 C38676 C38292 C38677 C38293 C38294 C38295 C38216 C38296 C38198 C38297 C38298 C38299 C38300 C38301 C38304

TRANSDERMAL TRANSMUCOSAL TRANSPLACENTAL TRANSTRACHEAL TRANSTYMPANIC UNASSIGNED UNKNOWN URETERAL URETHRAL VAGINAL -

T-DERMAL T-MUCOS T-PLACENT T-TRACHE T-TYMPAN UNAS UNKNOWN URETER URETH VAGIN

358 122 415 355 124 400 139 112 017 015

C38305 C38283 C38307 C38308 C38309 C38310 C38311 C38312 C38271 C38313