Home NDC 72888-142-22 LEVOFLOXACIN
Product NDC 72888-142
Requested package NDC 72888-142-22
11-digit product format 728880142
Labeler code 72888
Product ID 72888-142_2ffa08e2-0405-47bb-e063-6294a90a4fe0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LEVOFLOXACIN
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Advagen Pharma Limited
Application ANDA078282
Marketing category ANDA
Marketing start 2022-02-22
Substance LEVOFLOXACIN
Active strength 5 mg/mL
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 A078282-001 LEVOFLOXACIN LEVOFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2010-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078282-001 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 2026-08-01 22:54:32 2026-06 A078282-001 LEVOFLOXACIN 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2010-12-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A078282-001 AT 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base LEVOFLOXACIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOFLOXACIN 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6GNT3Y5LMF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314080 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 72888-142-22 LEVOFLOXACIN 1 in 1 CARTON SOLUTION 1 2 72888-142-22 LEVOFLOXACIN 5 mL in 1 BOTTLE SOLUTION 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-142 LEVOFLOXACIN SOLUTION [ADVAGEN PHARMA LIMITED] 2 Current NDC, 2 package rows 20250311_f2eb9444-333d-4b05-8cf3-2e6690a2bf99.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-142-22 72888014222 1 BOTTLE in 1 CARTON (72888-142-22) / 5 mL in 1 BOTTLE 1 bottle 2022-02-22 No No Current