ofloxacin

Product NDC: 70518-4147
11-digit product format: 705184147
Labeler code: 70518
Product ID: 70518-4147_5a0c47ce-3fca-d9da-e063-6394a90af062
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ofloxacin otic
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: REMEDYREPACK INC.
Application: ANDA216130
Marketing category: ANDA
Marketing start: 2024-07-22
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70518-4147		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-4147	70518-4147-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A216130-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT		2022-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216130-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216130-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2022-07-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216130-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216130-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216130-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216130-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216130-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216130-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216130-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216130-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216130-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216130-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216130-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216130-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216130-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216130-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216130-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216130-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216130-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216130-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216130-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216130-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216130-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216130-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216130-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216130-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216130-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216130-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216130-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216130-001	AT	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216130-001	AT	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
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
50bca624-4dc0-4d1b-a693-2eb602eaf2f2	Available on FDA.report

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4147	OFLOXACIN (OFLOXACIN OTIC) SOLUTION [REMEDYREPACK INC.]	1	Current NDC	20240724_50bca624-4dc0-4d1b-a693-2eb602eaf2f2.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	OFLOXACIN OTIC	REMEDYREPACK INC.	50bca624-4dc0-4d1b-a693-2eb602eaf2f2	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130 ndc (product): 70518-4147
ofloxacin	OFLOXACIN OTIC	REMEDYREPACK INC.	fe619d50-49bf-4fcc-9428-6108c45580eb	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
ofloxacin	OFLOXACIN OTIC	NorthStar RxLLC	b95114f6-6753-4217-b621-44fa34afc298	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
ofloxacin	OFLOXACIN OTIC	Lifestar Pharma LLC	0621700e-6315-47ff-a8ed-cccf7d6fc56a	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
ofloxacin	OFLOXACIN OTIC	Sportpharm LLC	3f5972db-4eaf-4237-944d-8f63eff7b9b1	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
Olfoxacin Otic Soln	OLFOXACIN OTIC SOLN	Direct_Rx	fda35d37-f36a-efc8-e053-6294a90a2bb8	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
ofloxacin	OFLOXACIN OTIC	A-S Medication Solutions	71949588-42e2-446c-b7ec-904c09b2f95f	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
ofloxacin	OFLOXACIN OTIC	NuCare Pharmaceuticals,Inc.	1e917318-cdc7-cd2c-e063-6294a90a0cc2	2024-08-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
ofloxacin	OFLOXACIN OTIC	Asclemed USA, Inc.	ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
ofloxacin	OFLOXACIN OTIC	Proficient Rx LP	79074efc-83ed-4473-bb86-9f635928ea92	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A4P49JAZ9H	OFLOXACIN	82419-36-1	OFLOXACIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4147-0	70518414700	10 mL in 1 BOTTLE, DROPPER (70518-4147-0)	10 ml	2024-07-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	REMEDYREPACK INC.	2026-08-27	HUMAN PRESCRIPTION DRUG LABEL	4