Ofloxacin Otic

Product NDC: 50090-1090
Requested package NDC: 50090-1090-0
11-digit product format: 500901090
Labeler code: 50090
Product ID: 50090-1090_5b341aaa-4e47-4c22-aebb-a5374dd21b83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: A-S Medication Solutions
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

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 1 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1090	50090-1090-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (package): 50090-1090-0 ndc (product): 50090-1090 ndc11 (package): 50090109000
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

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
9d4b1225-e20d-4ace-850a-506fd031cac7	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1090-0	2023-02-07	C162847	48780-1	f386c64a-0ab0-0266-e053-dadaa90a7c1a	Ofloxacin Otic Solution 0.3%
50090-1090-0	2023-01-30	C162847	48780-1	f386c64a-0ab0-0266-e053-dadaa90a7c1a	Ofloxacin Otic Solution 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1090-0	Ofloxacin Otic	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1090-0	ML - Milliliter	50090-1090	e95979cb-f7db-47e7-94ee-6b03fd6cf72e	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1090	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [A-S MEDICATION SOLUTIONS]	12	Current NDC, Legacy NDC, 1 package rows	20240719_9d4b1225-e20d-4ace-850a-506fd031cac7.zip

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1090-0	50090109000	5 mL in 1 BOTTLE, DROPPER (50090-1090-0)	5 ml	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Otic Solution 0.3%	A-S Medication Solutions	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	12