Levofloxacin

Product NDC: 55111-281
11-digit product format: 551110281
Labeler code: 55111
Product ID: 55111-281_c51f53eb-2f01-93dc-e7e6-695b20b639ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA076710
Marketing category: ANDA
Marketing start: 2011-06-20
Substance: LEVOFLOXACIN
Active strength: 750 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	750 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
55111-281-01	Levofloxacin	100 in 1 BOTTLE	TABLET, FILM COATED	100	21
55111-281-05	Levofloxacin	500 in 1 BOTTLE	TABLET, FILM COATED	500	21
55111-281-30	Levofloxacin	30 in 1 BOTTLE	TABLET, FILM COATED	30	21
55111-281-50	Levofloxacin	50 in 1 BOTTLE	TABLET, FILM COATED	50	21
55111-281-78	Levofloxacin	10 in 1 CARTON	TABLET, FILM COATED	10	21
55111-281-79	Levofloxacin	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-281-30	EA - Each	55111-281	3eb57102-d293-4b30-ad47-051e18ec2161	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 [DR. REDDY'S LABORATORIES LIMITED ]	9
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
crospovidone	INACTIVE INGREDIENT	68401960MK	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	9
Levofloxacin	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
Levofloxacin	ACTIVE MOIETY	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
crospovidone	INACTIVE INGREDIENT	68401960MK	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
Levofloxacin	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-281	LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]	21	Current NDC, Legacy NDC, 6 package rows	20240806_9b59428a-a23a-b2d9-982f-98f8a1ed381f.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
199884	levoFLOXacin 250 MG Oral Tablet	PSN	9b59428a-a23a-b2d9-982f-98f8a1ed381f	21
199885	levoFLOXacin 500 MG Oral Tablet	PSN	9b59428a-a23a-b2d9-982f-98f8a1ed381f	21
311296	levoFLOXacin 750 MG Oral Tablet	PSN	9b59428a-a23a-b2d9-982f-98f8a1ed381f	21
199884	levofloxacin 250 MG Oral Tablet	SCD	9b59428a-a23a-b2d9-982f-98f8a1ed381f	21
199885	levofloxacin 500 MG Oral Tablet	SCD	9b59428a-a23a-b2d9-982f-98f8a1ed381f	21
311296	levofloxacin 750 MG Oral Tablet	SCD	9b59428a-a23a-b2d9-982f-98f8a1ed381f	21
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	9b59428a-a23a-b2d9-982f-98f8a1ed381f	21
311296	levoFLOXacin 750 MG Oral Tablet	PSN	710c0c10-89a5-4954-8f74-acc187c5cf0f	17
311296	levofloxacin 750 MG Oral Tablet	SCD	710c0c10-89a5-4954-8f74-acc187c5cf0f	17
199884	levoFLOXacin 250 MG Oral Tablet	PSN	ac4001ca-882f-4d9b-a570-c1b9d7fd6830	6
199885	levoFLOXacin 500 MG Oral Tablet	PSN	ac4001ca-882f-4d9b-a570-c1b9d7fd6830	6
311296	levoFLOXacin 750 MG Oral Tablet	PSN	ac4001ca-882f-4d9b-a570-c1b9d7fd6830	6
199884	levofloxacin 250 MG Oral Tablet	SCD	ac4001ca-882f-4d9b-a570-c1b9d7fd6830	6
199885	levofloxacin 500 MG Oral Tablet	SCD	ac4001ca-882f-4d9b-a570-c1b9d7fd6830	6
311296	levofloxacin 750 MG Oral Tablet	SCD	ac4001ca-882f-4d9b-a570-c1b9d7fd6830	6
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	ac4001ca-882f-4d9b-a570-c1b9d7fd6830	6
199884	levoFLOXacin 250 MG Oral Tablet	PSN	bfe280be-0789-69fa-e053-2a95a90a0e13	5
199884	levoFLOXacin 250 MG Oral Tablet	PSN	2e88afd5-a9f3-4790-8945-80e12bdd4956	5
199885	levoFLOXacin 500 MG Oral Tablet	PSN	2e88afd5-a9f3-4790-8945-80e12bdd4956	5
199885	levoFLOXacin 500 MG Oral Tablet	PSN	bfe280be-0789-69fa-e053-2a95a90a0e13	5
311296	levoFLOXacin 750 MG Oral Tablet	PSN	2e88afd5-a9f3-4790-8945-80e12bdd4956	5
311296	levoFLOXacin 750 MG Oral Tablet	PSN	bfe280be-0789-69fa-e053-2a95a90a0e13	5
199884	levofloxacin 250 MG Oral Tablet	SCD	2e88afd5-a9f3-4790-8945-80e12bdd4956	5
199884	levofloxacin 250 MG Oral Tablet	SCD	bfe280be-0789-69fa-e053-2a95a90a0e13	5
199885	levofloxacin 500 MG Oral Tablet	SCD	2e88afd5-a9f3-4790-8945-80e12bdd4956	5
199885	levofloxacin 500 MG Oral Tablet	SCD	bfe280be-0789-69fa-e053-2a95a90a0e13	5
311296	levofloxacin 750 MG Oral Tablet	SCD	bfe280be-0789-69fa-e053-2a95a90a0e13	5
311296	levofloxacin 750 MG Oral Tablet	SCD	2e88afd5-a9f3-4790-8945-80e12bdd4956	5
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	2e88afd5-a9f3-4790-8945-80e12bdd4956	5
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	bfe280be-0789-69fa-e053-2a95a90a0e13	5
311296	levoFLOXacin 750 MG Oral Tablet	PSN	f2f090c2-3ee1-7689-e053-2995a90abe38	4
311296	levofloxacin 750 MG Oral Tablet	SCD	f2f090c2-3ee1-7689-e053-2995a90abe38	4
199885	levoFLOXacin 500 MG Oral Tablet	PSN	ecc5ff4e-9ce4-4778-9b92-c84f6b82b5b4	1
311296	levoFLOXacin 750 MG Oral Tablet	PSN	ecc5ff4e-9ce4-4778-9b92-c84f6b82b5b4	1
199885	levofloxacin 500 MG Oral Tablet	SCD	ecc5ff4e-9ce4-4778-9b92-c84f6b82b5b4	1
311296	levofloxacin 750 MG Oral Tablet	SCD	ecc5ff4e-9ce4-4778-9b92-c84f6b82b5b4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-281-01	55111028101	100 TABLET, FILM COATED in 1 BOTTLE (55111-281-01)		2011-06-20	0000-00-00	No	No	Current
55111-281-05	55111028105	500 TABLET, FILM COATED in 1 BOTTLE (55111-281-05)		2011-06-20	0000-00-00	No	No	Current
55111-281-30	55111028130	30 TABLET, FILM COATED in 1 BOTTLE (55111-281-30)		2011-06-20	0000-00-00	No	No	Current
55111-281-50	55111028150	50 TABLET, FILM COATED in 1 BOTTLE (55111-281-50)		2011-06-20	0000-00-00	No	No	Current
55111-281-78	55111028178	10 BLISTER PACK in 1 CARTON (55111-281-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-281-79)	10 blister pack	2011-06-20	0000-00-00	No	No	Current
55111-281-79	55111028179	10 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	REMEDYREPACK INC.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	17
Levofloxacin	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Levofloxacin	Major Pharmaceuticals	2025-09-11	HUMAN PRESCRIPTION DRUG LABEL	6
Levofloxacin	Golden State Medical Supply, Inc.	2024-09-16	HUMAN PRESCRIPTION DRUG LABEL	5
Levofloxacin	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited -FTO III	2024-06-29	HUMAN PRESCRIPTION DRUG LABEL	21
Levofloxacin	Blenheim Pharmacal, Inc.	2014-02-28	HUMAN PRESCRIPTION DRUG LABEL	1
Levofloxacin - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-04-24	HUMAN PRESCRIPTION DRUG LABEL	5

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#