Home NDC 50090-5425 Ofloxacin
Product NDC 50090-5425
11-digit product format 500905425
Labeler code 50090
Product ID 50090-5425_73ce8dc2-0fdd-4b1c-b144-9a7a3ded8b80
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ofloxacin
Dosage form SOLUTION
Route OPHTHALMIC
Labeler A-S Medication Solutions
Application ANDA078559
Marketing category ANDA
Marketing start 2014-12-15
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 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-5425-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-5425-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-5425-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-5425-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-5425-0 1332a3947898…d4bfe170f9cd…
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.
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A4P49JAZ9H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312075 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5425-0 Ofloxacin 1 in 1 CARTON SOLUTION 1 5 50090-5425-0 Ofloxacin 5 mL in 1 BOTTLE, PLASTIC SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5425 OFLOXACIN SOLUTION [A-S MEDICATION SOLUTIONS] 3 Current NDC, Legacy NDC, 2 package rows 20241025_537c6351-c7f1-47c9-95de-011bac850768.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 Marketing start Marketing end Sample Exclude flag Status 50090-5425-0 50090542500 1 BOTTLE, PLASTIC in 1 CARTON (50090-5425-0) / 5 mL in 1 BOTTLE, PLASTIC 2021-01-08 0000-00-00 No No Current