Home NDC 0078-0841 CILOXAN
Product NDC 0078-0841
11-digit product format 000780841
Labeler code 0078
Product ID 0078-0841_bae31988-364f-40e1-aaf4-c93248214781
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin hydrochloride
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
Application NDA020369
Marketing category NDA
Marketing start 1998-06-02
Marketing end 0000-00-00
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 3 mg/g
Pharmacologic classes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0078-0841 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0078-0841 0078-0841-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020369-001 CILOXAN CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30
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 · 42 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 2026-08-18 06:07:40 2026-07 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020369-001 CILOXAN EQ 0.3% BASE OINTMENT / OPHTHALMIC RLD, RS 1998-03-30 e64feba35796…
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0841 CILOXAN (CIPROFLOXACIN HYDROCHLORIDE) OINTMENT [NOVARTIS PHARMACEUTICALS CORPORATION] 3 Legacy NDC 20230628_7b557d15-bd97-42d2-adcb-d172b4216cb6.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CILOXAN CIPROFLOXACIN HYDROCHLORIDE Sandoz Inc 09ca5374-2a16-4a95-91b3-70591d78254e 2024-07-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 020369 application number: NDA020369
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0841-01 00078084101 3.5 g in 1 TUBE (0078-0841-01) 3.5 g 2021-03-01 0000-00-00 No No Current