CIPRO HC

Product NDC
50090-7631
11-digit product format
500907631
Labeler code
50090
Product ID
50090-7631_76e8bba5-b964-4dbe-a54e-c544db1f3555
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride and hydrocortisone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
A-S Medication Solutions
Application
NDA020805
Marketing category
NDA
Marketing start
1999-03-15
Substance
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
Active strength
2; 10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CIPRO HC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE2 mg/mL
HYDROCORTISONE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37, WI4X0X7BPJ
Rxcui213320, 309305

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
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48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
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
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
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36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
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61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
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de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7631-0CIPRO HC10 mL in 1 BOTTLESUSPENSION/ DROPS102
50090-7631-0CIPRO HC1 in 1 CARTONSUSPENSION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7631-0ML - Milliliter50090-76318bee6876-3582-4466-a633-89fc45f2840012025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213320Cipro HC 0.2 % / 1 % Otic SuspensionPSNd2c40b07-dc39-46c6-8ea1-b288589a46d12
309305ciprofloxacin 0.2 % / hydrocortisone 1 % Otic SuspensionPSNd2c40b07-dc39-46c6-8ea1-b288589a46d12
213320ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension [Cipro HC]SBDd2c40b07-dc39-46c6-8ea1-b288589a46d12
309305ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic SuspensionSCDd2c40b07-dc39-46c6-8ea1-b288589a46d12
213320Cipro HC (ciprofloxacin 0.2 % / hydrocortisone 1 % ) Otic SuspensionSYd2c40b07-dc39-46c6-8ea1-b288589a46d12
213320Cipro HC 2/10 Otic SuspensionSYd2c40b07-dc39-46c6-8ea1-b288589a46d12
309305ciprofloxacin 0.2 % / hydrocortisone 1 % Otic SuspensionSYd2c40b07-dc39-46c6-8ea1-b288589a46d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7631-0500907631001 BOTTLE in 1 CARTON (50090-7631-0) / 10 mL in 1 BOTTLE1 bottle2025-08-14NoNoHistorical