Levofloxacin

Product NDC: 25021-825
11-digit product format: 250210825
Labeler code: 25021
Product ID: 25021-825_f929da29-c793-42e9-b6a6-9c0eebc6c654
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA090343
Marketing category: ANDA
Marketing start: 2011-12-05
Marketing end: 2020-01-31
Substance: LEVOFLOXACIN
Active strength: 5 mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	25021-825		D	Discontinued by firm	2026-07-31
excluded package	package	25021-825	25021-825-81	D	Discontinued by firm	2026-07-31
excluded package	package	25021-825	25021-825-82	D	Discontinued by firm	2026-07-31
excluded package	package	25021-825	25021-825-83	D	Discontinued by firm	2026-07-31

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.

Application-product, TE code table
Application-product	TE code
A090343-001	AP
A090343-002	AP
A090343-003	AP

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090343-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090343-002	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090343-003	AP	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 · 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-825-81	ML - Milliliter	25021-825	c21df210-32ff-4212-913f-415a4d29fd80	1	2012-07-24
25021-825-82	ML - Milliliter	25021-825	420f9c02-94ad-4718-98d7-2c948af43922	1	2012-07-24
25021-825-83	ML - Milliliter	25021-825	cb359034-dc60-432f-bee1-b46d5386f2ae	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
levofloxacin	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	7
Levofloxacin Anhydrous	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	7
dextrose	INACTIVE INGREDIENT	IY9XDZ35W2	LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	7
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	7
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	7