Home NDC 11980-779 OCUFLOX
Product NDC 11980-779
11-digit product format 119800779
Labeler code 11980
Product ID 11980-779_4ba88457-b1b2-4bbc-b086-a2bab56752a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ofloxacin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Allergan, Inc.
Application NDA019921
Marketing category NDA
Marketing start 1993-08-01
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 N019921-001 OCUFLOX OFLOXACIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019921-001 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 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019921-001 OCUFLOX 0.3% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1993-07-30 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 OCUFLOX
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207202 Internal RxNorm lookup 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 11980-779-05 OCUFLOX 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 13 11980-779-05 OCUFLOX 1 in 1 CARTON SOLUTION/ DROPS 1 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11980-779 OCUFLOX (OFLOXACIN) SOLUTION/ DROPS [ALLERGAN, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250109_7aab4449-3dda-4e2c-8e40-b3244a548bf5.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 · 1 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 11980-779-05 11980077905 1 BOTTLE, DROPPER in 1 CARTON (11980-779-05) / 5 mL in 1 BOTTLE, DROPPER 1993-08-01 0000-00-00 No No Current