ofloxacin

Product NDC: 70756-609
11-digit product format: 707560609
Labeler code: 70756
Product ID: 70756-609_7556cd96-134e-4aaa-bf2d-7b6f9c8133c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ofloxacin otic
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Lifestar Pharma LLC
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 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
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
2026-02-19 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
2026-02-19 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…`

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
0621700e-6315-47ff-a8ed-cccf7d6fc56a	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
70756-609-15	ofloxacin	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70756-609-15	ML - Milliliter	70756-609	6e5d85d2-1fc5-4f3c-8da0-4205a5c727a7	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70756-609	OFLOXACIN (OFLOXACIN OTIC) SOLUTION [LIFESTAR PHARMA LLC]	5	Current NDC, Legacy NDC, 1 package rows	20230625_0621700e-6315-47ff-a8ed-cccf7d6fc56a.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
ofloxacin	OFLOXACIN OTIC	REMEDYREPACK INC.	fe619d50-49bf-4fcc-9428-6108c45580eb	2026-06-11	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
ofloxacin	OFLOXACIN OTIC	NorthStar RxLLC	b95114f6-6753-4217-b621-44fa34afc298	2023-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130
ofloxacin	OFLOXACIN OTIC	Lifestar Pharma LLC	0621700e-6315-47ff-a8ed-cccf7d6fc56a	2023-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216130 application number: ANDA216130 ndc (product): 70756-609

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	0621700e-6315-47ff-a8ed-cccf7d6fc56a	5
242446	ofloxacin 3 MG/ML Otic Solution	SCD	0621700e-6315-47ff-a8ed-cccf7d6fc56a	5
242446	ofloxacin 0.3 % Otic Solution	SY	0621700e-6315-47ff-a8ed-cccf7d6fc56a	5
242446	ofloxacin 0.3 % Otic Solution	PSN	243743a4-edca-4e3a-8fe4-4ed81bf5f556	3
242446	ofloxacin 0.3 % Otic Solution	PSN	fda35d37-f36a-efc8-e053-6294a90a2bb8	3
242446	ofloxacin 3 MG/ML Otic Solution	SCD	243743a4-edca-4e3a-8fe4-4ed81bf5f556	3
242446	ofloxacin 3 MG/ML Otic Solution	SCD	fda35d37-f36a-efc8-e053-6294a90a2bb8	3
242446	ofloxacin 0.3 % Otic Solution	SY	243743a4-edca-4e3a-8fe4-4ed81bf5f556	3
242446	ofloxacin 0.3 % Otic Solution	SY	fda35d37-f36a-efc8-e053-6294a90a2bb8	3
242446	ofloxacin 0.3 % Otic Solution	PSN	fe619d50-49bf-4fcc-9428-6108c45580eb	2
242446	ofloxacin 0.3 % Otic Solution	PSN	79074efc-83ed-4473-bb86-9f635928ea92	2
242446	ofloxacin 3 MG/ML Otic Solution	SCD	fe619d50-49bf-4fcc-9428-6108c45580eb	2
242446	ofloxacin 3 MG/ML Otic Solution	SCD	79074efc-83ed-4473-bb86-9f635928ea92	2
242446	ofloxacin 0.3 % Otic Solution	SY	79074efc-83ed-4473-bb86-9f635928ea92	2
242446	ofloxacin 0.3 % Otic Solution	SY	fe619d50-49bf-4fcc-9428-6108c45580eb	2
242446	ofloxacin 0.3 % Otic Solution	PSN	ef17b4bf-f20f-4a6d-e053-2a95a90ae494	1
242446	ofloxacin 0.3 % Otic Solution	PSN	71949588-42e2-446c-b7ec-904c09b2f95f	1
242446	ofloxacin 0.3 % Otic Solution	PSN	1d89cb5d-45ce-e814-e063-6294a90aeb78	1
242446	ofloxacin 0.3 % Otic Solution	PSN	ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c	1
242446	ofloxacin 3 MG/ML Otic Solution	SCD	ef17b4bf-f20f-4a6d-e053-2a95a90ae494	1
242446	ofloxacin 3 MG/ML Otic Solution	SCD	71949588-42e2-446c-b7ec-904c09b2f95f	1
242446	ofloxacin 3 MG/ML Otic Solution	SCD	1d89cb5d-45ce-e814-e063-6294a90aeb78	1
242446	ofloxacin 3 MG/ML Otic Solution	SCD	ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0c	1
242446	ofloxacin 0.3 % Otic Solution	SY	ef17b4bf-f20f-4a6d-e053-2a95a90ae494	1
242446	ofloxacin 0.3 % Otic Solution	SY	71949588-42e2-446c-b7ec-904c09b2f95f	1
242446	ofloxacin 0.3 % Otic Solution	SY	1d89cb5d-45ce-e814-e063-6294a90aeb78	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	Marketing end	Sample	Exclude flag	Status
70756-609-15	70756060915	5 mL in 1 BOTTLE, DROPPER (70756-609-15)	5 ml	2022-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	Sportpharm LLC	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	REMEDYREPACK INC.	2026-06-11	HUMAN PRESCRIPTION DRUG LABEL	3
Olfoxacin Otic Soln	Direct_Rx	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	3
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	A-S Medication Solutions	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	1
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	RedPharm Drug	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	1
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	1
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	Proficient Rx LP	2024-03-01	HUMAN PRESCRIPTION DRUG LABEL	2
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	RPK Pharmaceuticals, Inc.	2023-09-11	HUMAN PRESCRIPTION DRUG LABEL	3
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	Lifestar Pharma LLC \| Mankind Pharma Limited	2023-06-23	HUMAN PRESCRIPTION DRUG LABEL	5
Ofloxacin Otic Solution 0.3% (Sterile) Rx only	NuCare Pharmaceuticals,Inc.	2022-12-05	HUMAN PRESCRIPTION DRUG LABEL	1