Ofloxacin

Product NDC: 13985-602
Requested package NDC: 13985-602-05
11-digit product format: 139850602
Labeler code: 13985
Product ID: 13985-602_51308ecf-1ef6-495b-954f-455acd51501a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: MWI
Application: ANDA076407
Marketing category: ANDA
Marketing start: 2015-03-27
Marketing end: 0000-00-00
Substance: OFLOXACIN
Active strength: 3 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	13985-602	13985-602-05	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A076407-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2008-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076407-001	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	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076407-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2008-04-15	`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	A076407-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076407-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076407-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076407-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076407-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076407-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076407-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076407-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076407-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076407-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076407-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076407-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076407-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076407-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076407-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076407-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076407-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076407-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076407-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076407-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076407-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076407-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076407-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076407-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076407-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076407-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076407-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076407-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076407-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076407-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076407-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076407-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076407-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076407-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076407-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076407-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076407-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076407-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076407-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076407-001	AT	1	`cb3db0bc1861…`

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
13985-602-05	2024-01-30	C162847	48780-1	1030e365-6986-111a-e063-dadaa90a10e2	fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4
13985-602-10	2024-01-30	C162847	48780-1	1030e365-6986-111a-e063-dadaa90a10e2	fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13985-602-05	Ofloxacin	1 in 1 CARTON	SOLUTION/ DROPS	1	6
13985-602-05	Ofloxacin	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	6
13985-602-10	Ofloxacin	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	6
13985-602-10	Ofloxacin	1 in 1 CARTON	SOLUTION/ DROPS	1	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ofloxacin	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [MWI]	1
Ofloxacin	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION/ DROPS [MWI]	1
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN SOLUTION/ DROPS [MWI]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN SOLUTION/ DROPS [MWI]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN SOLUTION/ DROPS [MWI]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN SOLUTION/ DROPS [MWI]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN SOLUTION/ DROPS [MWI]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13985-602	OFLOXACIN SOLUTION/ DROPS [MWI]	6	Legacy NDC, 4 package rows	20220204_fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	NuCare Pharmaceuticals, Inc.	51f3d155-36df-4c40-e054-00144ff8d46c	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076407 application number: ANDA076407
Ofloxacin	OFLOXACIN	ARMAS PHARMACEUTICALS INC.	07ac850b-a983-fc21-e063-6394a90a21b2	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076407 application number: ANDA076407
Ofloxacin	OFLOXACIN	Proficient Rx LP	2d2807a8-19d5-4922-8270-a8885d61e851	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076407 application number: ANDA076407

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
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4	6
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4	6
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	fcd7c5d7-42f4-4dcb-bc84-d976fafd5df4	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13985-602-05	13985060205	1 BOTTLE, DROPPER in 1 CARTON (13985-602-05) > 5 mL in 1 BOTTLE, DROPPER	2015-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin - MWI \| Akorn Operating Company LLC \| Akorn AG \| Akorn	MWI \| Akorn Operating Company LLC \| Akorn AG \| Akorn	2022-02-03	HUMAN PRESCRIPTION DRUG LABEL	6