Home NDC 55545-1003 Ofloxacin
Product NDC 55545-1003
11-digit product format 555451003
Labeler code 55545
Product ID 55545-1003_d2b7e684-27f1-4ee7-b235-58b632ac9694
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ofloxacin
Dosage form SOLUTION
Route OPHTHALMIC
Labeler FDC Limited
Application ANDA078559
Marketing category ANDA
Marketing start 2014-12-15
Marketing end 0000-00-00
Substance OFLOXACIN
Active strength 3 mg/mL
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A078559-001 OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078559-001 AT
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078559-001 OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2009-02-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55545-1003-1 Ofloxacin 5 mL in 1 BOTTLE, PLASTIC SOLUTION 5 3 55545-1003-1 Ofloxacin 1 in 1 CARTON SOLUTION 1 3 55545-1003-2 Ofloxacin 1 in 1 CARTON SOLUTION 1 3 55545-1003-2 Ofloxacin 10 mL in 1 BOTTLE, PLASTIC SOLUTION 10 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55545-1003 OFLOXACIN SOLUTION [FDC LIMITED] 3 Legacy NDC, 4 package rows 20171122_b4d09b4d-bc6a-405b-91c8-e4246336a1f7.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 55545-1003-1 55545100301 5 mL in 1 BOTTLE, PLASTIC 5 ml Historical 55545-1003-2 55545100302 1 in 1 CARTON Historical