ofloxacin

Product NDC: 76420-748
11-digit product format: 764200748
Labeler code: 76420
Product ID: 76420-748_1aaaf971-7d69-9422-e063-6394a90a2a69
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ofloxacin otic
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Asclemed USA, Inc.
Application: ANDA216130
Marketing category: ANDA
Marketing start: 2022-07-15
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 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: 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
ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-748-05	ofloxacin	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-748	OFLOXACIN (OFLOXACIN OTIC) SOLUTION [ASCLEMED USA, INC.]	1	Current NDC, 1 package rows	20240613_ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c.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
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 ndc (product): 76420-748
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
242446	ofloxacin 0.3 % Otic Solution	PSN	ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c	1
242446	ofloxacin 3 MG/ML Otic Solution	SCD	ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c	1
242446	ofloxacin 0.3 % Otic Solution	SY	ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-748-05	76420074805	5 mL in 1 BOTTLE, DROPPER (76420-748-05)	5 ml	2024-06-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	1