Home NDC 69315-320 OFLOXACIN
Product NDC 69315-320
11-digit product format 693150320
Labeler code 69315
Product ID 69315-320_88154ff7-fd59-4fd3-a82e-e55d3b6192bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OFLOXACIN
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler Leading Pharma, LLC
Application ANDA217903
Marketing category ANDA
Marketing start 2024-03-01
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 A217903-001 OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217903-001 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 2026-02-19 14:30 UTC 2026-02 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217903-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2024-01-05 a50c72e98297…
Observed Orange Book normalized TE history# 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 242446 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 69315-320-05 OFLOXACIN 5 mL in 1 BOTTLE, DROPPER SOLUTION 5 4 69315-320-10 OFLOXACIN 10 mL in 1 BOTTLE, DROPPER SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69315-320 OFLOXACIN SOLUTION [LEADING PHARMA, LLC] 4 Current NDC, 2 package rows 20240410_e43bf505-1030-49cd-a144-19b997fb5575.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69315-320-05 69315032005 5 mL in 1 BOTTLE, DROPPER (69315-320-05) 5 ml 2024-03-01 No No Current 69315-320-10 69315032010 10 mL in 1 BOTTLE, DROPPER (69315-320-10) 10 ml 2024-03-01 No No Current