Ofloxacin

Product NDC: 68788-8761
11-digit product format: 687888761
Labeler code: 68788
Product ID: 68788-8761_d359da57-ad0c-4b2d-87bf-70c596c7a371
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ofloxacin
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA076513
Marketing category: ANDA
Marketing start: 2024-11-11
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 1.

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
A076513-001	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
A076513-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076513-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076513-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076513-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076513-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076513-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076513-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076513-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076513-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076513-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076513-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076513-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076513-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076513-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076513-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076513-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076513-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076513-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076513-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076513-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076513-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076513-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076513-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076513-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076513-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076513-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076513-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076513-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076513-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076513-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076513-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076513-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076513-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076513-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076513-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076513-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076513-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076513-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076513-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076513-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076513-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076513-001	AT	1	`cb3db0bc1861…`

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
f7916bb3-7593-45f8-b9de-98e0f2d57227	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8761-5	Ofloxacin	1 in 1 CARTON	SOLUTION	1		2
68788-8761-5	Ofloxacin	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8761-5	ML - Milliliter	68788-8761	2835877e-f34b-4ff5-8a01-e9fa4bbd74f0	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8761	OFLOXACIN SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1	Current NDC, 2 package rows	20241113_f7916bb3-7593-45f8-b9de-98e0f2d57227.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	St. Mary's Medical Park Pharmacy	2d55b26d-9d12-ca29-e063-6294a90ab237	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513
Ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	f7916bb3-7593-45f8-b9de-98e0f2d57227	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513 ndc (product): 68788-8761
Ofloxacin	OFLOXACIN	Apotex Corp.	5117d567-2004-c5ed-1391-f8831864696f	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513
Ofloxacin	OFLOXACIN	A-S Medication Solutions	ab5b0e34-ac5c-4c0c-b104-934b319ae011	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513
Ofloxacin	OFLOXACIN	Proficient Rx LP	5a9de529-6f85-467a-97b0-8ce124c31173	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513
Ofloxacin	OFLOXACIN	A-S Medication Solutions	392d458f-8815-49f4-9c2b-0e721e295b1f	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513
Ofloxacin	OFLOXACIN	NuCare Pharmceuticals,Inc.	102c825b-af5c-42e7-e063-6394a90a81a1	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076513 application number: ANDA076513

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
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	f7916bb3-7593-45f8-b9de-98e0f2d57227	2
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	f7916bb3-7593-45f8-b9de-98e0f2d57227	2
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	f7916bb3-7593-45f8-b9de-98e0f2d57227	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-8761-5	68788876105	1 BOTTLE, DROPPER in 1 CARTON (68788-8761-5) / 5 mL in 1 BOTTLE, DROPPER	2024-11-11	No	No	Current