Ofloxacin Otic

Product NDC: 68071-1630
11-digit product format: 680711630
Labeler code: 68071
Product ID: 68071-1630_2a2f62dc-8ba6-7ca9-e063-6294a90aca76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: NuCare Pharmaceuticals,Inc.
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#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1630-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1630-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1630-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1630-3	`1332a3947898…`	`d4bfe170f9cd…`

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
76f461da-0e15-aa6d-e053-2a91aa0a9808	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#

Effective, Related label table
Effective	Related label
2024-07-25	Ofloxacin Otic Solution 0.3%
2023-01-30	Ofloxacin Otic Solution 0.3%
2021-02-11	Ofloxacin Otic Solution 0.3%
2021-01-29	Ofloxacin Otic Solution 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1630-3	Ofloxacin Otic	10 mL in 1 BOTTLE	SOLUTION	10		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1630	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241228_76f461da-0e15-aa6d-e053-2a91aa0a9808.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
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 ndc (product): 68071-1630
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	76f461da-0e15-aa6d-e053-2a91aa0a9808	5
242446	ofloxacin 3 MG/ML Otic Solution	SCD	76f461da-0e15-aa6d-e053-2a91aa0a9808	5
242446	ofloxacin 0.3 % Otic Solution	SY	76f461da-0e15-aa6d-e053-2a91aa0a9808	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1630-3	68071163003	10 mL in 1 BOTTLE (68071-1630-3)	10 ml	2018-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Otic Solution 0.3%	NuCare Pharmaceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	5