Ofloxacin

Product NDC: 55111-162
11-digit product format: 551110162
Labeler code: 55111
Product ID: 55111-162_889d4bcc-0b25-f208-dea4-aedf75197224
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ofloxacin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA077098
Marketing category: ANDA
Marketing start: 2006-02-10
Marketing end: 0000-00-00
Substance: OFLOXACIN
Active strength: 400 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	55111-162		D	Discontinued by firm	2026-10-16
excluded package	package	55111-162	55111-162-01	D	Discontinued by firm	2026-10-16
excluded package	package	55111-162	55111-162-05	D	Discontinued by firm	2026-10-16
excluded package	package	55111-162	55111-162-30	D	Discontinued by firm	2026-10-16
excluded package	package	55111-162	55111-162-50	D	Discontinued by firm	2026-10-16
excluded package	package	55111-162	55111-162-78	D	Discontinued by firm	2026-10-16

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 · 72 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	55111-162-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-162-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-162-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-162-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55111-162-50	`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	55111-162-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-162-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-162-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-162-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55111-162-50	`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	55111-162-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-162-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-162-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-162-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55111-162-50	`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	55111-162-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-162-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-162-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-162-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55111-162-50	`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	55111-162-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-162-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-162-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-162-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55111-162-50	`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	55111-162-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-162-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-162-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-162-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55111-162-50	`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	55111-162-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-162-78	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-162-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-162-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55111-162-50	`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	55111-162-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-162-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-162-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-162-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55111-162-50	`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	55111-162-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-162-78	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-162-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-162-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55111-162-50	`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	55111-162-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-162-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-162-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-162-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55111-162-50	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077098-001	OFLOXACIN	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10
A077098-002	OFLOXACIN	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10
A077098-003	OFLOXACIN	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077098-001	AB
A077098-002	AB
A077098-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077098-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2006-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077098-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2006-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077098-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2006-02-10	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A077098-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077098-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077098-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077098-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077098-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077098-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077098-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077098-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077098-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077098-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077098-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077098-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077098-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077098-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077098-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077098-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077098-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077098-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077098-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077098-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077098-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077098-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077098-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077098-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077098-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077098-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077098-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077098-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077098-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077098-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077098-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077098-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077098-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077098-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077098-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077098-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077098-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077098-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077098-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077098-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-162-01	EA - Each	55111-162	e29fa706-a538-4d1b-b0d5-49416935769f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ofloxacin	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
ofloxacin	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
HYPROMELLOSE 2910 (5 CPS)	INACTIVE INGREDIENT	R75537T0T4	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OFLOXACIN TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A4P49JAZ9H	OFLOXACIN	82419-36-1	OFLOXACIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-162-01	55111016201	100 TABLET, COATED in 1 BOTTLE (55111-162-01)		2006-02-10	0000-00-00	No	No	Current
55111-162-05	55111016205	500 TABLET, COATED in 1 BOTTLE (55111-162-05)		2006-02-10	0000-00-00	No	No	Current
55111-162-30	55111016230	30 TABLET, COATED in 1 BOTTLE (55111-162-30)		2006-02-10	0000-00-00	No	No	Current
55111-162-50	55111016250	50 TABLET, COATED in 1 BOTTLE (55111-162-50)		2006-02-10	0000-00-00	No	No	Current
55111-162-78	55111016278	10 BLISTER PACK in 1 CARTON (55111-162-78) > 10 TABLET, COATED in 1 BLISTER PACK (55111-162-79)	10 blister pack	2006-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited(FTO III)	2018-12-05	HUMAN PRESCRIPTION DRUG LABEL	11