CDER DATA STANDARDS MANUAL

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

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