Ofloxacin Otic

Product NDC: 60505-0363
11-digit product format: 605050363
Labeler code: 60505
Product ID: 60505-0363_b1c42fcf-f4c3-117c-4fa2-7a68c821acd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Apotex Corp.
Application: ANDA076527
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
A076527-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT		2007-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076527-001	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	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`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	A076527-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076527-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076527-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076527-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076527-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076527-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076527-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076527-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076527-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076527-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076527-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076527-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076527-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076527-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076527-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076527-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076527-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076527-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076527-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076527-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076527-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076527-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076527-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076527-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076527-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076527-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076527-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076527-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076527-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076527-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076527-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076527-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076527-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076527-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076527-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076527-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076527-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076527-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076527-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076527-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ofloxacin Otic
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
242446	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
8db221b1-32f3-f6ca-e404-71f56a860d08	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	Strength	SPL version
60505-0363-1	Ofloxacin Otic	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		9
60505-0363-2	Ofloxacin Otic	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0363-1	ML - Milliliter	60505-0363	8f1ac64d-1c59-4066-a076-274fa11d6cdb	1	2012-07-24
60505-0363-2	ML - Milliliter	60505-0363	8b30d5b9-551f-4a4a-b531-a287e7cb6738	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]	1
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0363	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [APOTEX CORP.]	8	Current NDC, Legacy NDC, 2 package rows	20241105_8db221b1-32f3-f6ca-e404-71f56a860d08.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OFLOXACIN OTIC	OFLOXACIN	DIRECT RX	a7952956-b64a-0f99-e053-2995a90a0f91	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	REMEDYREPACK INC.	42366170-e536-46a1-9735-d76e5820a9de	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Apotex Corp.	8db221b1-32f3-f6ca-e404-71f56a860d08	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527 ndc (product): 60505-0363
Ofloxacin Otic	OFLOXACIN	NuCare Pharmaceuticals,Inc.	76f461da-0e15-aa6d-e053-2a91aa0a9808	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	4f4048b2-3ae8-441a-b1e3-7311fac00f94	2024-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	567fa672-5fd0-4a1d-bc12-054a9ac16117	2024-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	A-S Medication Solutions	9d4b1225-e20d-4ace-850a-506fd031cac7	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	NuCare Pharmaceuticals,Inc.	79ef87c3-1f09-1625-e053-2991aa0a84ae	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Proficient Rx LP	14e6e355-3a87-43dc-80a2-070b9df93bf1	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527

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
242446	ofloxacin 0.3 % Otic Solution	PSN	567fa672-5fd0-4a1d-bc12-054a9ac16117	106
242446	ofloxacin 3 MG/ML Otic Solution	SCD	567fa672-5fd0-4a1d-bc12-054a9ac16117	106
242446	ofloxacin 0.3 % Otic Solution	SY	567fa672-5fd0-4a1d-bc12-054a9ac16117	106
242446	ofloxacin 0.3 % Otic Solution	PSN	7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa	100
242446	ofloxacin 0.3 % Otic Solution	PSN	4f4048b2-3ae8-441a-b1e3-7311fac00f94	100
242446	ofloxacin 3 MG/ML Otic Solution	SCD	7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa	100
242446	ofloxacin 3 MG/ML Otic Solution	SCD	4f4048b2-3ae8-441a-b1e3-7311fac00f94	100
242446	ofloxacin 0.3 % Otic Solution	SY	7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa	100
242446	ofloxacin 0.3 % Otic Solution	SY	4f4048b2-3ae8-441a-b1e3-7311fac00f94	100
242446	ofloxacin 0.3 % Otic Solution	PSN	9d4b1225-e20d-4ace-850a-506fd031cac7	12
242446	ofloxacin 3 MG/ML Otic Solution	SCD	9d4b1225-e20d-4ace-850a-506fd031cac7	12
242446	ofloxacin 0.3 % Otic Solution	SY	9d4b1225-e20d-4ace-850a-506fd031cac7	12
242446	ofloxacin 0.3 % Otic Solution	PSN	8db221b1-32f3-f6ca-e404-71f56a860d08	9
242446	ofloxacin 3 MG/ML Otic Solution	SCD	8db221b1-32f3-f6ca-e404-71f56a860d08	9
242446	ofloxacin 0.3 % Otic Solution	SY	8db221b1-32f3-f6ca-e404-71f56a860d08	9
242446	ofloxacin 0.3 % Otic Solution	PSN	7592cf3f-7d4b-436f-89f0-a3686570fef8	5
242446	ofloxacin 0.3 % Otic Solution	PSN	76f461da-0e15-aa6d-e053-2a91aa0a9808	5
242446	ofloxacin 3 MG/ML Otic Solution	SCD	7592cf3f-7d4b-436f-89f0-a3686570fef8	5
242446	ofloxacin 3 MG/ML Otic Solution	SCD	76f461da-0e15-aa6d-e053-2a91aa0a9808	5
242446	ofloxacin 0.3 % Otic Solution	SY	7592cf3f-7d4b-436f-89f0-a3686570fef8	5
242446	ofloxacin 0.3 % Otic Solution	SY	76f461da-0e15-aa6d-e053-2a91aa0a9808	5
242446	ofloxacin 0.3 % Otic Solution	PSN	a7952956-b64a-0f99-e053-2995a90a0f91	4
242446	ofloxacin 0.3 % Otic Solution	PSN	79ef87c3-1f09-1625-e053-2991aa0a84ae	4
242446	ofloxacin 0.3 % Otic Solution	PSN	14e6e355-3a87-43dc-80a2-070b9df93bf1	4
242446	ofloxacin 3 MG/ML Otic Solution	SCD	14e6e355-3a87-43dc-80a2-070b9df93bf1	4
242446	ofloxacin 3 MG/ML Otic Solution	SCD	a7952956-b64a-0f99-e053-2995a90a0f91	4
242446	ofloxacin 3 MG/ML Otic Solution	SCD	79ef87c3-1f09-1625-e053-2991aa0a84ae	4
242446	ofloxacin 0.3 % Otic Solution	SY	79ef87c3-1f09-1625-e053-2991aa0a84ae	4
242446	ofloxacin 0.3 % Otic Solution	SY	a7952956-b64a-0f99-e053-2995a90a0f91	4
242446	ofloxacin 0.3 % Otic Solution	SY	14e6e355-3a87-43dc-80a2-070b9df93bf1	4
242446	ofloxacin 0.3 % Otic Solution	PSN	42366170-e536-46a1-9735-d76e5820a9de	3
242446	ofloxacin 3 MG/ML Otic Solution	SCD	42366170-e536-46a1-9735-d76e5820a9de	3
242446	ofloxacin 0.3 % Otic Solution	SY	42366170-e536-46a1-9735-d76e5820a9de	3
242446	ofloxacin 0.3 % Otic Solution	PSN	1b3cebc2-0079-2e29-e063-6394a90ae0fa	1
242446	ofloxacin 3 MG/ML Otic Solution	SCD	1b3cebc2-0079-2e29-e063-6394a90ae0fa	1
242446	ofloxacin 0.3 % Otic Solution	SY	1b3cebc2-0079-2e29-e063-6394a90ae0fa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0363-1	60505036301	5 mL in 1 BOTTLE, DROPPER (60505-0363-1)	5 ml	2004-05-14	0000-00-00	No	No	Current
60505-0363-2	60505036302	10 mL in 1 BOTTLE, DROPPER (60505-0363-2)	10 ml	2004-05-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OFLAXACIN OTIC	DIRECT RX	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	4
Ofloxacin Otic Solution 0.3%	Bryant Ranch Prepack	2025-10-30	HUMAN PRESCRIPTION DRUG LABEL	100
Ofloxacin Otic Solution 0.3%	REMEDYREPACK INC.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	3
Ofloxacin Otic Solution 0.3%	Apotex Corp. \| Apotex Inc.	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	9
Ofloxacin Otic Solution 0.3%	NuCare Pharmaceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	5
Ofloxacin Otic Solution 0.3%	Bryant Ranch Prepack	2024-09-20	HUMAN PRESCRIPTION DRUG LABEL	100
Ofloxacin Otic Solution 0.3%	Bryant Ranch Prepack	2024-09-19	HUMAN PRESCRIPTION DRUG LABEL	106
Ofloxacin Otic Solution 0.3%	A-S Medication Solutions	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	12
Ofloxacin Otic Solution 0.3%	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	4
Ofloxacin Otic Solution 0.3%	Redpharm Drug	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	1
Ofloxacin Otic Solution 0.3%	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Ofloxacin Otic Solution 0.3%	Proficient Rx LP	2022-09-01	HUMAN PRESCRIPTION DRUG LABEL	4
Ofloxacin Otic Solution 0.3%	Preferred Pharmaceuticals, Inc.	2019-02-06	HUMAN PRESCRIPTION DRUG LABEL	4