Levofloxacin

Product NDC: 65862-537
11-digit product format: 658620537
Labeler code: 65862
Product ID: 65862-537_00620274-6cae-4cb8-bd5d-8f80732ae3ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA201043
Marketing category: ANDA
Marketing start: 2011-06-20
Substance: LEVOFLOXACIN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Levofloxacin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOFLOXACIN	500 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6GNT3Y5LMF
Rxcui	199884, 199885, 311296

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3	Product name	2	20210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90c	Product name	4	20200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6d	Product name	1	20190618
aea4a616-4dfe-45f6-94bb-8b9063056ceb	Product name	6	20190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1	Product name	1	20180821
5a6c788d-375b-4565-a8ae-67c179a30c93	Product name	1	20180212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-537-10	Levofloxacin	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	23
65862-537-10	Levofloxacin	10 in 1 CARTON	TABLET, FILM COATED	10	23
65862-537-50	Levofloxacin	50 in 1 BOTTLE	TABLET, FILM COATED	50	23
65862-537-99	Levofloxacin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-537-50	EA - Each	65862-537	4ee5ad1c-8f82-497f-bd52-2c12a064e232	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-537	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	23	Current NDC, Legacy NDC, 4 package rows	20240630_529ac72c-c4a0-4001-8cf9-b94f5bf7265c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6GNT3Y5LMF	LEVOFLOXACIN	138199-71-0	LEVOFLOXACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199885	levoFLOXacin 500 MG Oral Tablet	PSN	a5ae33ad-4703-4cb2-8618-6439c906be99	31
199885	levofloxacin 500 MG Oral Tablet	SCD	a5ae33ad-4703-4cb2-8618-6439c906be99	31
199885	levoFLOXacin 500 MG Oral Tablet	PSN	b8defac4-9deb-433b-928e-0ef4ee0123a2	30
199885	levofloxacin 500 MG Oral Tablet	SCD	b8defac4-9deb-433b-928e-0ef4ee0123a2	30
199885	levoFLOXacin 500 MG Oral Tablet	PSN	b1a4aabb-42af-4133-8e82-0c7ec8fa79c3	24
199885	levofloxacin 500 MG Oral Tablet	SCD	b1a4aabb-42af-4133-8e82-0c7ec8fa79c3	24
199884	levoFLOXacin 250 MG Oral Tablet	PSN	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199885	levoFLOXacin 500 MG Oral Tablet	PSN	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
311296	levoFLOXacin 750 MG Oral Tablet	PSN	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199884	levofloxacin 250 MG Oral Tablet	SCD	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199885	levofloxacin 500 MG Oral Tablet	SCD	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
311296	levofloxacin 750 MG Oral Tablet	SCD	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199885	levoFLOXacin 500 MG Oral Tablet	PSN	52687d77-247e-44e8-ae46-3abd3a2505ce	9
199885	levofloxacin 500 MG Oral Tablet	SCD	52687d77-247e-44e8-ae46-3abd3a2505ce	9
199885	levoFLOXacin 500 MG Oral Tablet	PSN	479cf183-88e5-4d57-bc08-22943e63c16c	7
199885	levofloxacin 500 MG Oral Tablet	SCD	479cf183-88e5-4d57-bc08-22943e63c16c	7
199885	levoFLOXacin 500 MG Oral Tablet	PSN	4304fbd4-b0a4-08a6-e054-00144ff88e88	6
199885	levoFLOXacin 500 MG Oral Tablet	PSN	afd5cb35-4232-f8b1-e053-2a95a90a8c5b	6
199885	levoFLOXacin 500 MG Oral Tablet	PSN	9f944b63-9b60-437a-ba57-d14d7976bc32	6
199885	levofloxacin 500 MG Oral Tablet	SCD	afd5cb35-4232-f8b1-e053-2a95a90a8c5b	6
199885	levofloxacin 500 MG Oral Tablet	SCD	4304fbd4-b0a4-08a6-e054-00144ff88e88	6
199885	levofloxacin 500 MG Oral Tablet	SCD	9f944b63-9b60-437a-ba57-d14d7976bc32	6
199885	levoFLOXacin 500 MG Oral Tablet	PSN	638e4e2c-ba0d-43f7-87a0-1b860a9e651a	3
199885	levofloxacin 500 MG Oral Tablet	SCD	638e4e2c-ba0d-43f7-87a0-1b860a9e651a	3
199884	levoFLOXacin 250 MG Oral Tablet	PSN	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
199885	levoFLOXacin 500 MG Oral Tablet	PSN	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
311296	levoFLOXacin 750 MG Oral Tablet	PSN	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
199884	levofloxacin 250 MG Oral Tablet	SCD	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
199885	levofloxacin 500 MG Oral Tablet	SCD	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
311296	levofloxacin 750 MG Oral Tablet	SCD	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-537-10	65862053710	10 BLISTER PACK in 1 CARTON (65862-537-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2011-06-20	0000-00-00	No	No	Current
65862-537-50	65862053750	50 TABLET, FILM COATED in 1 BOTTLE (65862-537-50)		2011-06-20	0000-00-00	No	No	Current
65862-537-99	65862053799	1000 TABLET, FILM COATED in 1 BOTTLE (65862-537-99)		2011-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	REMEDYREPACK INC.	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	6
Levofloxacin	PD-Rx Pharmaceuticals, Inc.	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	31
Levofloxacin	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	24
Levofloxacin	PD-Rx Pharmaceuticals, Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	30
Levofloxacin 500mg Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Levofloxacin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	6
Levofloxacin	Aurobindo Pharma Limited \| Aurolife Pharma LLC \| APL HEALTHCARE LIMITED	2024-06-20	Human Prescription Drug Label	23
Levofloxacin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-05-13	HUMAN PRESCRIPTION DRUG LABEL	1
Levofloxacin	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	3
Levofloxacin	Blenheim Pharmacal, Inc.	2015-09-11	Human Prescription Drug Label	9
Levofloxacin	ReadyMeds	2014-05-05	Human Prescription Drug Label	7

Levofloxacin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#