Home NDC 70518-4752 Ofloxacin
Product NDC 70518-4752
11-digit product format 705184752
Labeler code 70518
Product ID 70518-4752_5b9b86b7-8c50-71fd-e063-6394a90a62ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ofloxacin
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler REMEDYREPACK INC.
Application ANDA215038
Marketing category ANDA
Marketing start 2026-09-16
Substance OFLOXACIN
Active strength 3 mg/mL
Pharmacologic classes Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A215038-001 OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215038-001 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.
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 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ofloxacin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OFLOXACIN 3 mg/mL
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 Ofloxacin OFLOXACIN Rising Pharma Holdings, Inc. 2e912ed6-51e8-40c3-bf10-2af092c63be8 2026-01-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 215038 application number: ANDA215038
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-4752-0 70518475200 1 BOTTLE, DROPPER in 1 CARTON (70518-4752-0) / 5 mL in 1 BOTTLE, DROPPER 2026-09-16 No No Current