Home NDC 44567-436 Levofloxacin
Product NDC 44567-436
11-digit product format 445670436
Labeler code 44567
Product ID 44567-436_e6bfbccc-f54c-4d4d-b268-b4fc803e372b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler WG Critical Care, LLC
Application ANDA090343
Marketing category ANDA
Marketing start 2016-04-14
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090343-001 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE / INJECTION AP RS 2011-07-07 A090343-002 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE / INJECTION AP RS 2011-07-07 A090343-003 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE / INJECTION AP RS 2011-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A090343-001 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 250MG/50ML (EQ 5MG/ML) INJECTABLE / INJECTION AP RS 2011-07-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A090343-002 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 500MG/100ML (EQ 5MG/ML) INJECTABLE / INJECTION AP RS 2011-07-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A090343-003 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 750MG/150ML (EQ 5MG/ML) INJECTABLE / INJECTION AP RS 2011-07-07 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Levofloxacin LEVOFLOXACIN Sagent Pharmaceuticals 699fbdb8-a6fd-476a-9b80-08197d869534 2026-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090343 application number: ANDA090343 Levofloxacin LEVOFLOXACIN Hospira, Inc 5a1534af-aa1c-4f1d-ba9f-9415b14e1af2 2025-11-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090343 application number: ANDA090343 Levofloxacin LEVOFLOXACIN WG Critical Care, LLC 9020cdeb-65fe-458f-bbbd-69265a49906e 2024-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090343 application number: ANDA090343 ndc (product): 44567-436
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665497 Internal RxNorm lookup 1665507 Internal RxNorm lookup 1665515 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 44567-436-24 Levofloxacin 1 in 1 POUCH INJECTION, SOLUTION 1 11 44567-436-24 Levofloxacin 24 in 1 CARTON INJECTION, SOLUTION 24 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-436 LEVOFLOXACIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20250206_9020cdeb-65fe-458f-bbbd-69265a49906e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44567-436-24 44567043624 24 POUCH in 1 CARTON (44567-436-24) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 24 pouch 2016-04-14 0000-00-00 No No Current