Home NDC 0078-0799 CIPRODEX
Product NDC 0078-0799
11-digit product format 000780799
Labeler code 0078
Product ID 0078-0799_535b147b-58b1-4027-8126-0b64be0ed6b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin and dexamethasone
Dosage form SUSPENSION/ DROPS
Route AURICULAR (OTIC)
Labeler Novartis Pharmaceuticals Corporation
Application NDA021537
Marketing category NDA
Marketing start 2003-08-04
Marketing end 0000-00-00
Substance CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
Active strength 3 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 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021537-001 CIPRODEX CIPROFLOXACIN; DEXAMETHASONE 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021537-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC RLD, RS 2003-07-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC RLD, RS 2003-07-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC RLD, RS 2003-07-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC RLD, RS 2003-07-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021537-001 CIPRODEX 0.3%;0.1% SUSPENSION/DROPS / OTIC AB RLD, RS 2003-07-18 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021537-001 6284804 2020-08-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 6359016 2020-08-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021537-001 9149486 2022-09-13 U-1578 Drug product 2015-11-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021537-001 9345714 2022-09-13 U-1578 Drug product 2016-06-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021537-001 9402805 2022-09-13 U-1679 Drug product 2016-08-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021537-001 9402805 2022-09-13 U-1578 Drug product 2016-08-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021537-001 8846650 2025-06-04 U-1578 Drug product 2014-10-03 bb7c543d1eb4…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0799 CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] 6 Legacy NDC 20230627_3e2cf3ea-a8f2-42e3-8424-9a6d6f0a4cb3.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0799-75 00078079975 1 BOTTLE in 1 CARTON (0078-0799-75) > 7.5 mL in 1 BOTTLE 1 bottle 2020-07-28 0000-00-00 No No Current 0078-0799-98 00078079998 1 BOTTLE in 1 CARTON (0078-0799-98) > .5 mL in 1 BOTTLE 1 bottle 2020-07-28 0000-00-00 Yes No Current