Home NDC 64980-432 Ofloxacin
Product NDC 64980-432
11-digit product format 649800432
Labeler code 64980
Product ID 64980-432_53f7e16a-6146-4c09-b3bf-4af9984f5b15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ofloxacin
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler Rising Pharma Holdings, Inc.
Application ANDA215038
Marketing category ANDA
Marketing start 2022-07-01
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 A215038-001 OFLOXACIN OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215038-001 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 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC 2022-01-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215038-001 OFLOXACIN 0.3% SOLUTION/DROPS / OTIC AT 2022-01-19 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 64980-432-01 Ofloxacin 10 mL in 1 BOTTLE, DROPPER SOLUTION 10 4 64980-432-01 Ofloxacin 1 in 1 CARTON SOLUTION 1 4 64980-432-05 Ofloxacin 5 mL in 1 BOTTLE, DROPPER SOLUTION 5 4 64980-432-05 Ofloxacin 1 in 1 CARTON SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-432 OFLOXACIN SOLUTION [RISING PHARMA HOLDINGS, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20240901_2e912ed6-51e8-40c3-bf10-2af092c63be8.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 64980-432-01 64980043201 1 BOTTLE, DROPPER in 1 CARTON (64980-432-01) / 10 mL in 1 BOTTLE, DROPPER 2022-07-01 0000-00-00 No No Current 64980-432-05 64980043205 1 BOTTLE, DROPPER in 1 CARTON (64980-432-05) / 5 mL in 1 BOTTLE, DROPPER 2022-07-01 0000-00-00 No No Current