Levofloxacin

Product NDC: 53002-2350
11-digit product format: 530022350
Labeler code: 53002
Product ID: 53002-2350_0b2a71e5-7e92-425b-a2e6-0f246504d3eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA201043
Marketing category: ANDA
Marketing start: 2011-06-20
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-2350		I	Inactivated by FDA	2026-08-11
excluded package	package	53002-2350	53002-2350-1	I	Inactivated by FDA	2026-08-11
excluded package	package	53002-2350	53002-2350-3	I	Inactivated by FDA	2026-08-11
excluded package	package	53002-2350	53002-2350-5	I	Inactivated by FDA	2026-08-11
excluded package	package	53002-2350	53002-2350-7	I	Inactivated by FDA	2026-08-11
excluded package	package	53002-2350	53002-2350-9	I	Inactivated by FDA	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 54 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2350-7	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2350-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2350-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2350-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2350-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2350-7	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2350-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2350-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2350-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2350-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2350-7	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2350-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2350-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2350-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2350-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2350-7	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2350-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2350-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2350-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2350-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2350-7	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2350-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2350-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2350-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2350-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2350-7	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2350-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2350-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2350-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2350-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2350-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2350-7	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2350-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2350-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2350-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2350-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2350-7	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2350-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2350-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2350-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2350-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2350-7	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2350-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2350-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2350-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-2350-1	2025-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-3	2025-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-5	2025-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-7	2025-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-9	2025-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-1	2023-06-07	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-3	2023-06-07	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-5	2023-06-07	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-7	2023-06-07	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-9	2023-06-07	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-1	2023-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-3	2023-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-5	2023-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-7	2023-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
53002-2350-9	2023-01-30	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-2350-1	Levofloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10	3
53002-2350-3	Levofloxacin	3 in 1 BOTTLE	TABLET, FILM COATED	3	3
53002-2350-5	Levofloxacin	5 in 1 BOTTLE	TABLET, FILM COATED	5	3
53002-2350-7	Levofloxacin	7 in 1 BOTTLE	TABLET, FILM COATED	7	3
53002-2350-9	Levofloxacin	14 in 1 BOTTLE	TABLET, FILM COATED	14	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2350	LEVOFLOXACIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 5 package rows	20230609_638e4e2c-ba0d-43f7-87a0-1b860a9e651a.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
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	638e4e2c-ba0d-43f7-87a0-1b860a9e651a	3
199885	levofloxacin 500 MG Oral Tablet	SCD	638e4e2c-ba0d-43f7-87a0-1b860a9e651a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2350-1	53002235001	10 TABLET, FILM COATED in 1 BOTTLE (53002-2350-1)	2019-01-01	0000-00-00	No	No	Current
53002-2350-3	53002235003	3 TABLET, FILM COATED in 1 BOTTLE (53002-2350-3)	2019-01-01	0000-00-00	No	No	Current
53002-2350-5	53002235005	5 TABLET, FILM COATED in 1 BOTTLE (53002-2350-5)	2019-01-01	0000-00-00	No	No	Current
53002-2350-7	53002235007	7 TABLET, FILM COATED in 1 BOTTLE (53002-2350-7)	2019-01-01	0000-00-00	No	No	Current
53002-2350-9	53002235009	14 TABLET, FILM COATED in 1 BOTTLE (53002-2350-9)	2019-01-01	0000-00-00	No	No	Current