Home NDC 0065-0654-35 CILOXAN
Product NDC 0065-0654
Requested package NDC 0065-0654-35
11-digit product format 000650654
Labeler code 0065
Product ID 0065-0654_360b6496-01a7-4afb-93f2-fccd473070d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin hydrochloride
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA020369
Marketing category NDA
Marketing start 1998-06-02
Marketing end 2022-01-31
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 3 mg/g
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Socrata Ingredients# 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 0065-0654-35 00065065435 3.5 g in 1 TUBE (0065-0654-35) 3.5 g 1998-06-02 2022-01-31 No No Current