Ofloxacin Ophth Soln

Product NDC: 72189-472
Requested package NDC: 72189-472-05
11-digit product format: 721890472
Labeler code: 72189
Product ID: 72189-472_4d3a583a-dad5-8766-e063-6394a90a525f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin Ophth Soln
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Direct_Rx
Application: ANDA215886
Marketing category: ANDA
Marketing start: 2023-05-22
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
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-472	72189-472-05	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-472	72189-472-05	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A215886-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2022-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215886-001	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	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215886-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2022-11-23	`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	A215886-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215886-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215886-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215886-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215886-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215886-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215886-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215886-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215886-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215886-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215886-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215886-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215886-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215886-001	AT	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215886-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215886-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215886-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215886-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215886-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215886-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215886-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215886-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215886-001	AT	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215886-001	AT	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ofloxacin Ophth Soln
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
312075	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
fc4d4b14-1eeb-0fba-e053-6394a90a738e	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
72189-472-05	Ofloxacin Ophth Soln	5 mL in 1 CARTON	SOLUTION/ DROPS	5		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-472-05	ML - Milliliter	72189-472	5f7324fe-6d95-4fae-a56b-c936460fbe34	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-472	OFLOXACIN OPHTH SOLN SOLUTION/ DROPS [DIRECT_RX]	2	Current NDC, 1 package rows	20250123_fc4d4b14-1eeb-0fba-e053-6394a90a738e.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ofloxacin	OFLOXACIN	Preferred Pharmaceuticals Inc.	306ed758-3c43-4f42-bd44-562ec65891dc	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
ofloxacin	OFLOXACIN	REMEDYREPACK INC.	d97651cc-d9ea-4be4-8ea1-3d0278582dd5	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
Ofloxacin Ophth Soln	OFLOXACIN OPHTH SOLN	Direct_Rx	fc4d4b14-1eeb-0fba-e053-6394a90a738e	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886 ndc (package): 72189-472-05 ndc (product): 72189-472 ndc11 (package): 72189047205
ofloxacin	OFLOXACIN	NuCare Pharmaceuticals, Inc.	4484283c-7839-e75d-e063-6394a90a8639	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
ofloxacin	OFLOXACIN	A-S Medication Solutions	8fd1eba2-2ed2-40a8-ae10-957b07434fe5	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
ofloxacin	OFLOXACIN	Lifestar Pharma LLC	871d63f4-41c1-4b30-903c-11fbf0d4c1f8	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
ofloxacin	OFLOXACIN	Major Pharmaceuticals	2d7a1f80-1c59-49e6-aff7-aedacade2dd6	2024-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
ofloxacin	OFLOXACIN	NorthStar RxLLC	7c98c671-aefa-48c3-971a-001f16aa72a8	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
ofloxacin	OFLOXACIN	NuCare Pharmaceuticals,Inc.	ff9776b3-a244-e1ea-e053-6294a90aeb7b	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
ofloxacin	OFLOXACIN	Proficient Rx LP	0c4e0b81-a344-4678-97d2-b15dc2857882	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886
ofloxacin	OFLOXACIN	A-S Medication Solutions	48dc8354-9a36-427b-ade9-818db6bfb01b	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215886 application number: ANDA215886

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	fc4d4b14-1eeb-0fba-e053-6394a90a738e	3
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	fc4d4b14-1eeb-0fba-e053-6394a90a738e	3
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	fc4d4b14-1eeb-0fba-e053-6394a90a738e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-472-05	72189047205	5 mL in 1 CARTON (72189-472-05)	5 ml	2023-05-22	No	No	Current