OFLOXACIN

Product NDC: 75834-112
11-digit product format: 758340112
Labeler code: 75834
Product ID: 75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OFLOXACIN
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA091656
Marketing category: ANDA
Marketing start: 2016-07-15
Substance: OFLOXACIN
Active strength: 400 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	75834-112		D	Discontinued by firm	2026-09-14
excluded package	package	75834-112	75834-112-01	D	Discontinued by firm	2026-09-14
excluded package	package	75834-112	75834-112-05	D	Discontinued by firm	2026-09-14
excluded package	package	75834-112	75834-112-50	D	Discontinued by firm	2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091656-001	OFLOXACIN	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18
A091656-002	OFLOXACIN	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18
A091656-003	OFLOXACIN	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091656-001	AB
A091656-002	AB
A091656-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091656-002	OFLOXACIN	300MG	TABLET / ORAL	AB	2014-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091656-003	OFLOXACIN	400MG	TABLET / ORAL	AB	2014-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091656-001	OFLOXACIN	200MG	TABLET / ORAL	AB	2014-09-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091656-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091656-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091656-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091656-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091656-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091656-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091656-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091656-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091656-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091656-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091656-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091656-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091656-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091656-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091656-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091656-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091656-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091656-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091656-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091656-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091656-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091656-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091656-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091656-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091656-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091656-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091656-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091656-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091656-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091656-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091656-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091656-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091656-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091656-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091656-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091656-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091656-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091656-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091656-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091656-001	AB	1	`301d65b070ca…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f9d82093-3de1-4841-9a42-67222d61a0cf	Product name	4	20250515
bbed5f06-a6b7-a443-70ac-77518a9524b7	Product name	7	20250311
41679fed-052c-574b-6b40-cadcbc315b79	Product name	2	20150401

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
75834-112-01	2022-02-15	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-05	2022-02-15	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-50	2022-02-15	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-01	2022-01-28	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-05	2022-01-28	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-50	2022-01-28	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-01	2020-05-06	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-05	2020-05-06	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-50	2020-05-06	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-01	2020-01-31	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-05	2020-01-31	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
75834-112-50	2020-01-31	OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75834-112-01	OFLOXACIN	100 in 1 BOTTLE	TABLET, COATED	100	4
75834-112-05	OFLOXACIN	500 in 1 BOTTLE	TABLET, COATED	500	4
75834-112-50	OFLOXACIN	50 in 1 BOTTLE	TABLET, COATED	50	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-112-01	EA - Each	75834-112	5d28be87-10a5-485f-84a4-1863bd1b3fe4	1	2016-12-07
75834-112-50	EA - Each	75834-112	bce7d25a-d463-477c-bc34-fb79c36424f3	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-112	OFLOXACIN TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20220216_ee1bf431-97fa-4aba-9cc3-0cfcea779ca2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OFLOXACIN	OFLOXACIN	Modavar Pharmaceuticals LLC	93ed9f70-b44f-496b-bdfc-c1bd5f1c260b	2026-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091656 application number: ANDA091656
OFLOXACIN	OFLOXACIN	Cadila Pharmaceuticals Limited	c677b35c-0432-4ee5-af57-1f95449c48b6	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091656 application number: ANDA091656

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198048	ofloxacin 200 MG Oral Tablet	PSN	ee1bf431-97fa-4aba-9cc3-0cfcea779ca2	4
198049	ofloxacin 300 MG Oral Tablet	PSN	ee1bf431-97fa-4aba-9cc3-0cfcea779ca2	4
198050	ofloxacin 400 MG Oral Tablet	PSN	ee1bf431-97fa-4aba-9cc3-0cfcea779ca2	4
198048	ofloxacin 200 MG Oral Tablet	SCD	ee1bf431-97fa-4aba-9cc3-0cfcea779ca2	4
198049	ofloxacin 300 MG Oral Tablet	SCD	ee1bf431-97fa-4aba-9cc3-0cfcea779ca2	4
198050	ofloxacin 400 MG Oral Tablet	SCD	ee1bf431-97fa-4aba-9cc3-0cfcea779ca2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-112-01	75834011201	100 TABLET, COATED in 1 BOTTLE (75834-112-01)	2016-07-15	0000-00-00	No	No	Current
75834-112-05	75834011205	500 TABLET, COATED in 1 BOTTLE (75834-112-05)	2016-07-15	0000-00-00	No	No	Current
75834-112-50	75834011250	50 TABLET, COATED in 1 BOTTLE (75834-112-50)	2016-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.	Nivagen Pharmaceuticals, Inc.	2022-02-15	HUMAN PRESCRIPTION DRUG LABEL	4