Ofloxacin

Product NDC: 70518-3573
Requested package NDC: 70518-3573-1
11-digit product format: 705183573
Labeler code: 70518
Product ID: 70518-3573_59031643-ea3b-a49e-e063-6294a90a6ec9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: REMEDYREPACK INC.
Application: ANDA076622
Marketing category: ANDA
Marketing start: 2022-11-07
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
A076622-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2004-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076622-001	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.

Product history page 1 of 2 · 43 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	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A076622-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076622-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076622-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076622-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076622-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076622-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076622-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076622-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076622-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076622-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076622-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076622-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076622-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076622-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076622-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076622-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076622-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076622-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076622-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076622-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076622-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076622-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076622-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076622-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076622-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076622-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076622-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076622-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076622-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076622-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076622-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076622-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076622-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076622-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076622-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076622-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076622-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076622-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076622-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076622-001	AT	1	`f41ea6bd6efb…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
A4P49JAZ9H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312075	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
38d0bbce-58ca-4fc1-a887-87b61fef9a87	Available on FDA.report

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3573	OFLOXACIN SOLUTION/ DROPS [REMEDYREPACK INC.]	3	Current NDC, Legacy NDC	20240116_38d0bbce-58ca-4fc1-a887-87b61fef9a87.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	REMEDYREPACK INC.	38d0bbce-58ca-4fc1-a887-87b61fef9a87	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622 ndc (package): 70518-3573-1 ndc (product): 70518-3573 ndc11 (package): 70518357301
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals, Inc.	0c01de7a-a885-4bf0-8df0-7c62170b7850	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622
Ofloxacin	OFLOXACIN	Bausch & Lomb Incorporated	ad40954d-0b1d-47c5-8bd5-8a1efd9a7153	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622
Ofloxacin	OFLOXACIN	A-S Medication Solutions	1838671d-e312-442a-b0bc-6702d6a8965c	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	af861f20-5ec8-2883-e053-2a95a90a2312	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	ae6b5cb0-aa18-a6d2-e053-2995a90a525d	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622
Ofloxacin	OFLOXACIN	A-S Medication Solutions	ff88214e-19b5-428d-a10d-91c3edc89a66	2023-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622
Ofloxacin	OFLOXACIN	Proficient Rx LP	c8020ad4-ac74-4ceb-863e-94da605cf23f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076622 application number: ANDA076622

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	Marketing start	Sample	Exclude flag	Status
70518-3573-1	70518357301	1 BOTTLE, DROPPER in 1 CARTON (70518-3573-1) / 10 mL in 1 BOTTLE, DROPPER	2026-08-12	No	No	Current