Ofloxacin

Product NDC: 24208-434
11-digit product format: 242080434
Labeler code: 24208
Product ID: 24208-434_37639b58-1d0f-206e-e063-6294a90a293a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: ANDA076622
Marketing category: ANDA
Marketing start: 2004-05-14
Substance: OFLOXACIN
Active strength: 3 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A076622-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-05-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076622-001	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	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…`
2022-09-29 23:25 UTC	2022-09	A076622-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076622-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ofloxacin
Listing expiration: 2026-12-31

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
ad40954d-0b1d-47c5-8bd5-8a1efd9a7153	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
41679fed-052c-574b-6b40-cadcbc315b79	Product name	2	20150401
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-434-05	Ofloxacin	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	14
24208-434-05	Ofloxacin	1 in 1 CARTON	SOLUTION/ DROPS	1	14
24208-434-10	Ofloxacin	1 in 1 CARTON	SOLUTION/ DROPS	1	14
24208-434-10	Ofloxacin	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-434-05	ML - Milliliter	24208-434	17a52039-d648-42ee-9f71-f3d2e784e496	1	2012-07-24
24208-434-10	ML - Milliliter	24208-434	1b91eac8-3177-4419-bd84-f24ce2123bfc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	3
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS, INC.]	3
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN SOLUTION/ DROPS [UNIT DOSE SERVICES]	2
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-434	OFLOXACIN SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	13	Current NDC, Legacy NDC, 4 package rows	20230630_ad40954d-0b1d-47c5-8bd5-8a1efd9a7153.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	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 ndc (product): 24208-434
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	ad40954d-0b1d-47c5-8bd5-8a1efd9a7153	14
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	ad40954d-0b1d-47c5-8bd5-8a1efd9a7153	14
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	ad40954d-0b1d-47c5-8bd5-8a1efd9a7153	14
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	0c01de7a-a885-4bf0-8df0-7c62170b7850	6
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	0c01de7a-a885-4bf0-8df0-7c62170b7850	6
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	0c01de7a-a885-4bf0-8df0-7c62170b7850	6
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	ff88214e-19b5-428d-a10d-91c3edc89a66	5
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	c8020ad4-ac74-4ceb-863e-94da605cf23f	5
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	ff88214e-19b5-428d-a10d-91c3edc89a66	5
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	c8020ad4-ac74-4ceb-863e-94da605cf23f	5
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	ff88214e-19b5-428d-a10d-91c3edc89a66	5
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	c8020ad4-ac74-4ceb-863e-94da605cf23f	5
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	1f42711d-f960-4832-acf5-97096aa6ad77	4
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	1f42711d-f960-4832-acf5-97096aa6ad77	4
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	1f42711d-f960-4832-acf5-97096aa6ad77	4
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	af861f20-5ec8-2883-e053-2a95a90a2312	3
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	ae6b5cb0-aa18-a6d2-e053-2995a90a525d	3
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	ae6b5cb0-aa18-a6d2-e053-2995a90a525d	3
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	af861f20-5ec8-2883-e053-2a95a90a2312	3
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	ae6b5cb0-aa18-a6d2-e053-2995a90a525d	3
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	af861f20-5ec8-2883-e053-2a95a90a2312	3
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	1838671d-e312-442a-b0bc-6702d6a8965c	1
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71	1
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	1d53674a-1377-ce2b-e063-6394a90a526f	1
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	1d53674a-1377-ce2b-e063-6394a90a526f	1
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	1838671d-e312-442a-b0bc-6702d6a8965c	1
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71	1
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	1838671d-e312-442a-b0bc-6702d6a8965c	1
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71	1
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	1d53674a-1377-ce2b-e063-6394a90a526f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-434-05	24208043405	1 BOTTLE, DROPPER in 1 CARTON (24208-434-05) / 5 mL in 1 BOTTLE, DROPPER	2004-05-14	0000-00-00	No	No	Current
24208-434-10	24208043410	1 BOTTLE, DROPPER in 1 CARTON (24208-434-10) / 10 mL in 1 BOTTLE, DROPPER	2004-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Ophthalmic Solution 0.3%	Preferred Pharmaceuticals, Inc.	2026-08-06	HUMAN PRESCRIPTION DRUG LABEL	7
Ofloxacin Ophthalmic Solution 0.3%	Bausch & Lomb Incorporated	2025-06-12	HUMAN PRESCRIPTION DRUG LABEL	14
Ofloxacin Ophthalmic Solution 0.3%	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
Ofloxacin Ophthalmic Solution 0.3%	A-S Medication Solutions	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	1
Ofloxacin Ophthalmic Solution 0.3% Sterile	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
Ofloxacin Ophthalmic Solution 0.3%	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
Ofloxacin Ophthalmic Solution 0.3%	RedPharm Drug	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	1
Ofloxacin Ophthalmic Solution 0.3%	REMEDYREPACK INC.	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	3
Ofloxacin Ophthalmic Solution 0.3%	A-S Medication Solutions	2023-08-14	HUMAN PRESCRIPTION DRUG LABEL	5
Ofloxacin Ophthalmic Solution 0.3% (Sterile)	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
Ofloxacin Ophthalmic Solution 0.3% (Sterile)	Preferred Pharmaceuticals, Inc.	2019-01-31	HUMAN PRESCRIPTION DRUG LABEL	6
Ofloxacin Ophthalmic Solution 0.3% (Sterile)	Unit Dose Services	2017-03-06	HUMAN PRESCRIPTION DRUG LABEL	4
Ofloxacin Ophthalmic Solution 0.3% (Sterile)	Rebel Distributors Corp	2010-10-22	HUMAN PRESCRIPTION DRUG LABEL	1