FDA.reportPublic FDA data

CIPRODEX

Product NDC
0065-8533
11-digit product format
000658533
Labeler code
0065
Product ID
0065-8533_c980ae27-6475-4463-b857-c6459a4f6962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Alcon Laboratories, Inc.
Application
NDA021537
Marketing category
NDA
Marketing start
2003-08-04
Marketing end
2021-11-30
Substance
CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength
3 mg/mL; mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-8533-02ML - Milliliter0065-8533d92d205f-d79a-4f83-bdf8-45353f9bbe2e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404630CIPRODEX 0.3 % / 0.1 % Otic SuspensionPSN3e64e493-ef35-43b9-b08c-3c30fe4a71641
404630CIPRODEX 0.3 % / 0.1 % Otic SuspensionPSN895c2307-aeeb-49fd-ac3d-750a463fc3ef1
403908ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic SuspensionPSN3e64e493-ef35-43b9-b08c-3c30fe4a71641
403908ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic SuspensionPSN895c2307-aeeb-49fd-ac3d-750a463fc3ef1
404630ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension [Ciprodex]SBD3e64e493-ef35-43b9-b08c-3c30fe4a71641
404630ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension [Ciprodex]SBD895c2307-aeeb-49fd-ac3d-750a463fc3ef1
403908ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSCD3e64e493-ef35-43b9-b08c-3c30fe4a71641
403908ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSCD895c2307-aeeb-49fd-ac3d-750a463fc3ef1
404630Ciprodex (ciprofloxacin (as ciprofloxacin HCl) 3 MG/ML / dexamethasone 1 MG/ML) Otic SuspensionSY3e64e493-ef35-43b9-b08c-3c30fe4a71641
404630Ciprodex (ciprofloxacin (as ciprofloxacin HCl) 3 MG/ML / dexamethasone 1 MG/ML) Otic SuspensionSY895c2307-aeeb-49fd-ac3d-750a463fc3ef1
404630Ciprodex (ciprofloxacin 0.3 % / dexamethasone 0.1 % ) Otic SuspensionSY3e64e493-ef35-43b9-b08c-3c30fe4a71641
404630Ciprodex (ciprofloxacin 0.3 % / dexamethasone 0.1 % ) Otic SuspensionSY895c2307-aeeb-49fd-ac3d-750a463fc3ef1
403908ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSY3e64e493-ef35-43b9-b08c-3c30fe4a71641
403908ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSY895c2307-aeeb-49fd-ac3d-750a463fc3ef1
403908ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic SuspensionSY3e64e493-ef35-43b9-b08c-3c30fe4a71641
403908ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic SuspensionSY895c2307-aeeb-49fd-ac3d-750a463fc3ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-8533-02000658533021 BOTTLE, DROPPER in 1 CARTON (0065-8533-02) > 7.5 mL in 1 BOTTLE, DROPPER2003-08-042021-11-30NoNoCurrent
0065-8533-11000658533111 BOTTLE, DROPPER in 1 CARTON (0065-8533-11) > .5 mL in 1 BOTTLE, DROPPER2017-05-190000-00-00YesNoCurrent