OFLOXACIN

Product NDC: 68071-5337
11-digit product format: 680715337
Labeler code: 68071
Product ID: 68071-5337_5d70a651-4697-3158-e063-6394a90a73db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OFLOXACIN
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA217904
Marketing category: ANDA
Marketing start: 2024-07-15
Substance: OFLOXACIN
Active strength: 3 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC], Quinolones [CS]
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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217904-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2024-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217904-001	AT

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.

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	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217904-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-04-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217904-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217904-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217904-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217904-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217904-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217904-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217904-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217904-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217904-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217904-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217904-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217904-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217904-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217904-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217904-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217904-001	AT	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217904-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OFLOXACIN	3 mg/mL

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%	SOLA Pharmaceuticals, LLC	4ca27244-ed70-4868-b2d8-8f97c3a52148	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217904 application number: ANDA217904
Ofloxacin	OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%	Caplin Steriles Limited	53f7ec2e-5b4c-4f8c-b8ba-7f8844e0c01b	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217904 application number: ANDA217904
OFLOXACIN	OFLOXACIN	Leading Pharma, LLC	7552729e-a41e-4eb1-8b37-b48a86112790	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217904 application number: ANDA217904

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	Sample	Exclude flag	Status
68071-5337-1	68071533701	10 mL in 1 BOTTLE, DROPPER (68071-5337-1)	10 ml	2026-10-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Ophthalmic Solution USP, 0.3% Sterile	NuCare Pharmaceuticals, Inc.	2026-10-09	HUMAN PRESCRIPTION DRUG LABEL	1