CIPRO

Product NDC
0078-0855
11-digit product format
000780855
Labeler code
0078
Product ID
0078-0855_eff6ee40-6e52-4f61-b54d-edc612543f71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride and hydrocortisone
Dosage form
SUSPENSION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020805
Marketing category
NDA
Marketing start
1999-03-15
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
Active strength
2 mg/mL; mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0078-0855DDiscontinued by firm2026-10-05
excluded packagepackage0078-08550078-0855-26DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0078-0855DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0078-08550078-0855-26DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020805-001CIPRO HCCIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONEEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICABRLD, RS1998-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020805-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICABRLD, RS1998-02-1084e616aacf4f…
2026-08-18 06:07:402026-07N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICABRLD, RS1998-02-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICABRLD, RS1998-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICABRLD, RS1998-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-103f01610625f2…
2019-09-15 20:21 UTC2019-09N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020805-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N020805-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020805-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020805-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020805-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0855-26ML - Milliliter0078-08557599f562-9fdd-4ac2-8d65-4c3bf814a4b412022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0855CIPRO HC (CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]2Legacy NDC20230628_eff6ee40-6e52-4f61-b54d-edc612543f71.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacin hydrochloride and hydrocortisoneCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONESandoz Incc0881bbe-cc95-45d4-9878-3bc8946eff262026-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEA-S Medication Solutionsd2c40b07-dc39-46c6-8ea1-b288589a46d12025-08-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONESandoz Incb26594a3-2adf-4954-8be0-5bd6f8de96712024-11-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEA-S Medication Solutionsab640d62-f470-4b50-818f-0c0a339047432023-11-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEAsclemed USA, Inc.eafad445-2735-434b-a1c6-e1c6b201d2cf2022-09-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213320Cipro HC 0.2 % / 1 % Otic SuspensionPSNab640d62-f470-4b50-818f-0c0a339047433
309305ciprofloxacin 0.2 % / hydrocortisone 1 % Otic SuspensionPSNab640d62-f470-4b50-818f-0c0a339047433
213320ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension [Cipro HC]SBDab640d62-f470-4b50-818f-0c0a339047433
309305ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic SuspensionSCDab640d62-f470-4b50-818f-0c0a339047433
213320Cipro HC (ciprofloxacin 0.2 % / hydrocortisone 1 % ) Otic SuspensionSYab640d62-f470-4b50-818f-0c0a339047433
213320Cipro HC 2/10 Otic SuspensionSYab640d62-f470-4b50-818f-0c0a339047433
309305ciprofloxacin 0.2 % / hydrocortisone 1 % Otic SuspensionSYab640d62-f470-4b50-818f-0c0a339047433
213320Cipro HC 0.2 % / 1 % Otic SuspensionPSNeafad445-2735-434b-a1c6-e1c6b201d2cf1
213320Cipro HC 0.2 % / 1 % Otic SuspensionPSN1e193692-45ce-3088-e063-6294a90a174e1
309305ciprofloxacin 0.2 % / hydrocortisone 1 % Otic SuspensionPSN1e193692-45ce-3088-e063-6294a90a174e1
309305ciprofloxacin 0.2 % / hydrocortisone 1 % Otic SuspensionPSNeafad445-2735-434b-a1c6-e1c6b201d2cf1
213320ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension [Cipro HC]SBD1e193692-45ce-3088-e063-6294a90a174e1
213320ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension [Cipro HC]SBDeafad445-2735-434b-a1c6-e1c6b201d2cf1
309305ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic SuspensionSCD1e193692-45ce-3088-e063-6294a90a174e1
309305ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic SuspensionSCDeafad445-2735-434b-a1c6-e1c6b201d2cf1
213320Cipro HC (ciprofloxacin 0.2 % / hydrocortisone 1 % ) Otic SuspensionSY1e193692-45ce-3088-e063-6294a90a174e1
213320Cipro HC (ciprofloxacin 0.2 % / hydrocortisone 1 % ) Otic SuspensionSYeafad445-2735-434b-a1c6-e1c6b201d2cf1
213320Cipro HC 2/10 Otic SuspensionSYeafad445-2735-434b-a1c6-e1c6b201d2cf1
213320Cipro HC 2/10 Otic SuspensionSY1e193692-45ce-3088-e063-6294a90a174e1
309305ciprofloxacin 0.2 % / hydrocortisone 1 % Otic SuspensionSYeafad445-2735-434b-a1c6-e1c6b201d2cf1
309305ciprofloxacin 0.2 % / hydrocortisone 1 % Otic SuspensionSY1e193692-45ce-3088-e063-6294a90a174e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0855-260007808552610 mL in 1 BOTTLE (0078-0855-26) 10 ml2022-03-080000-00-00NoNoCurrent