Ofloxacin

Product NDC: 53002-1604
11-digit product format: 530021604
Labeler code: 53002
Product ID: 53002-1604_507e9327-b3d4-40e3-93ad-66812a7042f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA076128
Marketing category: ANDA
Marketing start: 2008-03-17
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: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53002-1604		I	Inactivated by FDA		2026-08-11
excluded package	package	53002-1604	53002-1604-1	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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-1604-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-1604-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-1604-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-1604-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-1604-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-1604-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-1604-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-1604-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-1604-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-1604-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1604-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A076128-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076128-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076128-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	RS	2008-03-17	`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	A076128-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076128-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076128-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076128-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076128-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076128-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076128-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076128-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076128-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076128-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076128-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076128-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076128-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076128-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076128-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076128-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076128-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076128-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076128-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076128-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076128-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076128-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076128-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076128-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076128-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076128-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076128-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076128-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076128-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076128-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076128-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076128-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076128-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076128-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076128-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076128-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076128-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076128-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076128-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076128-001	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
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
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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	Ofloxacin Otic Solution 0.3% (Sterile) Rx only
2023-06-07	Ofloxacin Otic Solution 0.3% (Sterile) Rx only
2023-01-30	Ofloxacin Otic Solution 0.3% (Sterile) Rx only
2020-12-15	Ofloxacin Otic Solution 0.3% (Sterile) Rx only
2020-01-31	Ofloxacin Otic Solution 0.3% (Sterile) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-1604-1	Ofloxacin	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1604	OFLOXACIN SOLUTION [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 1 package rows	20230609_0c5bb891-b3db-4f9c-8392-4aed6e74b1a7.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	Redpharm Drug	2fbd51a5-462c-4741-e063-6394a90a0d87	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076128 application number: ANDA076128
Ofloxacin	OFLOXACIN	Bausch & Lomb Incorporated	c5484f1a-2321-453f-9469-dfcf709e2e2e	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076128 application number: ANDA076128
Ofloxacin	OFLOXACIN	Proficient Rx LP	bfe09726-9acb-4032-be91-ef2614662ae2	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076128 application number: ANDA076128

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	0c5bb891-b3db-4f9c-8392-4aed6e74b1a7	5
242446	ofloxacin 3 MG/ML Otic Solution	SCD	0c5bb891-b3db-4f9c-8392-4aed6e74b1a7	5
242446	ofloxacin 0.3 % Otic Solution	SY	0c5bb891-b3db-4f9c-8392-4aed6e74b1a7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1604-1	53002160401	5 mL in 1 BOTTLE, DROPPER (53002-1604-1)	5 ml	2017-09-01	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	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5