Levofloxacin

Product NDC: 43063-457
11-digit product format: 430630457
Labeler code: 43063
Product ID: 43063-457_4d52a1c6-bbc1-0b02-e063-6294a90afa45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA201043
Marketing category: ANDA
Marketing start: 2011-06-20
Substance: LEVOFLOXACIN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A201043-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20
A201043-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20
A201043-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A201043-001	AB
A201043-002	AB
A201043-003	AB

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.

Product history page 1 of 4 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201043-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201043-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201043-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201043-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levofloxacin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOFLOXACIN	500 mg/1

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
199885	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a5ae33ad-4703-4cb2-8618-6439c906be99	Available on FDA.report

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
43063-457-03	Levofloxacin	3 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	3	31
43063-457-05	Levofloxacin	5 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	5	31
43063-457-07	Levofloxacin	7 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	7	31
43063-457-10	Levofloxacin	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	31
43063-457-14	Levofloxacin	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	14	31
43063-457-20	Levofloxacin	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-457-05	EA - Each	43063-457	009e321f-7883-418e-9e0c-7178ab29a8b5	1	2013-08-02
43063-457-07	EA - Each	43063-457	44a9cf6a-71ec-464a-a65e-d26ccc34efff	1	2013-08-02
43063-457-10	EA - Each	43063-457	c6ca3e40-0606-420e-9c08-bdf1dda8ef63	1	2013-08-02
43063-457-14	EA - Each	43063-457	3c6c06ca-9fd3-48fe-b65e-0608f016a829	1	2021-05-05
43063-457-20	EA - Each	43063-457	356210a4-89ce-4dcf-8f36-21919b22c492	1	2023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-457	LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	30	Current NDC, Legacy NDC, 6 package rows	20250121_a5ae33ad-4703-4cb2-8618-6439c906be99.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	HAWAII REPACK, INC.	857f256c-88ac-4f73-9815-c2724edf2f1e	2026-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	9f944b63-9b60-437a-ba57-d14d7976bc32	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	a5ae33ad-4703-4cb2-8618-6439c906be99	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043 ndc (product): 43063-457
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	814450ae-439e-4a5d-8c60-9b21b6f14be5	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	b1a4aabb-42af-4133-8e82-0c7ec8fa79c3	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	b8defac4-9deb-433b-928e-0ef4ee0123a2	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Advanced Rx of Tennessee, LLC	afd5cb35-4232-f8b1-e053-2a95a90a8c5b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Aurobindo Pharma Limited	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Asclemed USA, Inc.	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	2024-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	30958610-3803-45e6-aa3c-d256decbe6e4	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-457-02	43063045702	2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-02)	2012-09-25	0000-00-00	No	No	Current
43063-457-03	43063045703	3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-03)	2012-09-25	0000-00-00	No	No	Current
43063-457-05	43063045705	5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-05)	2012-09-25	0000-00-00	No	No	Current
43063-457-07	43063045707	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-07)	2012-09-25	0000-00-00	No	No	Current
43063-457-10	43063045710	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-10)	2012-09-25	0000-00-00	No	No	Current
43063-457-14	43063045714	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-14)	2021-04-01	0000-00-00	No	No	Current
43063-457-20	43063045720	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-20)	2022-11-02	0000-00-00	No	No	Current