Levofloxacin

Product NDC: 21695-027
11-digit product format: 216950027
Labeler code: 21695
Product ID: 21695-027_f82ee9e3-5119-4be0-883c-5831386baef6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076361
Marketing category: ANDA
Marketing start: 2011-06-20
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 500 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-027		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-027	21695-027-03	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-027	21695-027-07	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-027	21695-027-10	I	Inactivated by FDA	2026-08-17

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-027-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-027-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-027-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-027-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-027-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-027-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-027-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-027-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-027-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-027-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-027-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-027-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-027-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-027-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-027-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-027-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-027-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-027-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-027-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-027-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-027-07	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-027-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-027-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-027-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-027-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-027-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-027-07	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-027-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-027-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-027-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-027-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-027-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-027-07	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-027-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-027-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-027-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-027-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-027-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-027-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-027-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-027-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-027-07	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-027-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-027-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-027-07	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A076361-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20
A076361-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20
A076361-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	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
A076361-001	AB
A076361-002	AB
A076361-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076361-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076361-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076361-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076361-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076361-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076361-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076361-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076361-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076361-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076361-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076361-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076361-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076361-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076361-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076361-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076361-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076361-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076361-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076361-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076361-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076361-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076361-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076361-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076361-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076361-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076361-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076361-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076361-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076361-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076361-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076361-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076361-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076361-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076361-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076361-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076361-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076361-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076361-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076361-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076361-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076361-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076361-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076361-001	AB	1	`1e350fbaab3a…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-027-03	2019-09-24	C162847	48780-1	934fe258-4809-48b1-e053-8cdaa90a720a	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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
21695-027-07	2019-09-24	C162847	48780-1	934fe258-4809-48b1-e053-8cdaa90a720a	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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
21695-027-10	2019-09-24	C162847	48780-1	934fe258-4809-48b1-e053-8cdaa90a720a	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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-027-03	Levofloxacin	3 in 1 BOTTLE	TABLET, FILM COATED	3	3
21695-027-07	Levofloxacin	7 in 1 BOTTLE	TABLET, FILM COATED	7	3
21695-027-10	Levofloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-027-03	EA - Each	21695-027	0cf9a395-3282-4d06-843d-746eff1930d0	1	2013-02-13
21695-027-07	EA - Each	21695-027	f7b4adbb-fcf5-4ca2-9471-35132242e794	1	2012-07-24
21695-027-10	EA - Each	21695-027	687a61c8-6328-4520-8d9a-ad78e634467d	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 [REBEL DISTRIBUTORS CORP]	3
LEVOFLOXACIN	ACTIVE MOIETY	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-027	LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	3	Legacy NDC, 3 package rows	20120511_312e65cb-897f-4c24-b17b-be7e8ce469bb.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	312e65cb-897f-4c24-b17b-be7e8ce469bb	3
199885	levoFLOXacin 500 MG Oral Tablet	PSN	312e65cb-897f-4c24-b17b-be7e8ce469bb	3
311296	levoFLOXacin 750 MG Oral Tablet	PSN	312e65cb-897f-4c24-b17b-be7e8ce469bb	3
199884	levofloxacin 250 MG Oral Tablet	SCD	312e65cb-897f-4c24-b17b-be7e8ce469bb	3
199885	levofloxacin 500 MG Oral Tablet	SCD	312e65cb-897f-4c24-b17b-be7e8ce469bb	3
311296	levofloxacin 750 MG Oral Tablet	SCD	312e65cb-897f-4c24-b17b-be7e8ce469bb	3
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	312e65cb-897f-4c24-b17b-be7e8ce469bb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-027-03	21695002703	3 in 1 BOTTLE	Historical
21695-027-07	21695002707	7 in 1 BOTTLE	Historical
21695-027-10	21695002710	10 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin - Rebel Distributors Corp	Rebel Distributors Corp	2011-07-19	HUMAN PRESCRIPTION DRUG LABEL	3