Ciprofloxacin and dexamethasone

Product NDC
70244-033
11-digit product format
702440033
Labeler code
70244
Product ID
70244-033_4f98e817-83be-84c5-e063-6294a90ada18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Sentiss Pharmaceuticals LLC
Application
ANDA215768
Marketing category
ANDA
Marketing start
2026-04-16
Substance
CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength
3; 1 mg/mL; mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin and dexamethasone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3 mg/mL
DEXAMETHASONE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37, 7S5I7G3JQL
Rxcui403908

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70244-033-01Ciprofloxacin and dexamethasone7.5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS7.53
70244-033-01Ciprofloxacin and dexamethasone1 in 1 CARTONSUSPENSION/ DROPS13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403908ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic SuspensionPSN355fa56f-d7a8-444e-9dec-8ba1fa4ab0d83
403908ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSCD355fa56f-d7a8-444e-9dec-8ba1fa4ab0d83
403908ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic SuspensionSY355fa56f-d7a8-444e-9dec-8ba1fa4ab0d83
403908ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic SuspensionSY355fa56f-d7a8-444e-9dec-8ba1fa4ab0d83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70244-033-01702440033011 BOTTLE, DROPPER in 1 CARTON (70244-033-01) / 7.5 mL in 1 BOTTLE, DROPPER2026-04-16NoNoCurrent