Home NDC 63187-734 Ofloxacin
Product NDC 63187-734
11-digit product format 631870734
Labeler code 63187
Product ID 63187-734_6fdf3036-94ca-4ad4-ae32-395156115512
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ofloxacin
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Proficient Rx LP
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 2026-12-31
Current FDA listing Yes 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 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63187-734-05 Ofloxacin 1 in 1 CARTON SOLUTION 1 4 63187-734-05 Ofloxacin 5 mL in 1 BOTTLE, PLASTIC SOLUTION 5 4 63187-734-10 Ofloxacin 1 in 1 CARTON SOLUTION 1 4 63187-734-10 Ofloxacin 10 mL in 1 BOTTLE, PLASTIC SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-734 OFLOXACIN SOLUTION [PROFICIENT RX LP] 4 Current NDC, Legacy NDC, 4 package rows 20200218_a2089612-de4b-4d78-b311-fa2524bd37f6.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 63187-734-05 63187073405 1 BOTTLE, PLASTIC in 1 CARTON (63187-734-05) / 5 mL in 1 BOTTLE, PLASTIC 2016-07-01 0000-00-00 No No Current 63187-734-10 63187073410 1 BOTTLE, PLASTIC in 1 CARTON (63187-734-10) / 10 mL in 1 BOTTLE, PLASTIC 2016-07-01 0000-00-00 No No Current