Home NDC 68071-2454-5 Ofloxacin
Product NDC 68071-2454
Requested package NDC 68071-2454-5
11-digit product format 680712454
Labeler code 68071
Product ID 68071-2454_c548aea8-5869-1415-e053-2a95a90acd40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ofloxacin Otic
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA211525
Marketing category ANDA
Marketing start 2020-03-17
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 2022-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A211525-001 OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211525-001 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 · 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 2026-09-14 22:38:34 2026-08 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211525-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2019-08-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2454 OFLOXACIN (OFLOXACIN OTIC) SOLUTION [NUCARE PHARMACEUTICALS,INC.] 1 Legacy NDC 20210622_c548aea8-5868-1415-e053-2a95a90acd40.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68071-2454-5 68071245405 1 BOTTLE, DROPPER in 1 CARTON (68071-2454-5) > 5 mL in 1 BOTTLE, DROPPER 2021-06-21 0000-00-00 No No Current