Ofloxacin

Product NDC: 64980-515
11-digit product format: 649800515
Labeler code: 64980
Product ID: 64980-515_8a9b999e-89bc-44ec-b974-729f66dc0bfa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA078559
Marketing category: ANDA
Marketing start: 2014-12-15
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
A078559-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2009-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078559-001	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	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`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	A078559-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078559-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078559-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078559-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078559-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078559-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078559-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078559-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078559-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078559-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078559-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078559-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078559-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078559-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078559-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078559-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078559-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078559-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078559-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078559-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078559-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078559-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078559-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078559-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078559-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078559-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078559-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078559-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078559-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078559-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078559-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078559-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078559-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078559-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078559-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078559-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078559-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078559-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078559-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078559-001	AT	1	`cb3db0bc1861…`

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
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
c76d8dc7-9a66-471b-814b-ef7f3605ec93	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
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	SPL version
64980-515-01	Ofloxacin	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10	9
64980-515-01	Ofloxacin	1 in 1 CARTON	SOLUTION	1	9
64980-515-05	Ofloxacin	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5	9
64980-515-05	Ofloxacin	1 in 1 CARTON	SOLUTION	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-515-01	ML - Milliliter	64980-515	2f740d8a-26fe-48ec-b1fa-7be86216dfd9	1	2015-05-05
64980-515-05	ML - Milliliter	64980-515	f2910eb4-7b81-4f06-bfc0-617549822144	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-515	OFLOXACIN SOLUTION [RISING PHARMA HOLDINGS, INC.]	8	Current NDC, Legacy NDC, 4 package rows	20240901_c76d8dc7-9a66-471b-814b-ef7f3605ec93.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	ST. MARY'S MEDICAL PARK PHARMACY	27c247e5-ef93-e9a5-e063-6394a90a2e1e	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559
Ofloxacin	OFLOXACIN	A-S Medication Solutions	537c6351-c7f1-47c9-95de-011bac850768	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559
Ofloxacin	OFLOXACIN	Rising Pharma Holdings, Inc.	c76d8dc7-9a66-471b-814b-ef7f3605ec93	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559 ndc (product): 64980-515
Ofloxacin	OFLOXACIN	Proficient Rx LP	a2089612-de4b-4d78-b311-fa2524bd37f6	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559

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	c76d8dc7-9a66-471b-814b-ef7f3605ec93	9
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	c76d8dc7-9a66-471b-814b-ef7f3605ec93	9
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	c76d8dc7-9a66-471b-814b-ef7f3605ec93	9
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	537c6351-c7f1-47c9-95de-011bac850768	5
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	537c6351-c7f1-47c9-95de-011bac850768	5
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	537c6351-c7f1-47c9-95de-011bac850768	5
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	a2089612-de4b-4d78-b311-fa2524bd37f6	4
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	a2089612-de4b-4d78-b311-fa2524bd37f6	4
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	a2089612-de4b-4d78-b311-fa2524bd37f6	4
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	1ece23ae-2d7c-d6d7-e063-6394a90ac3b1	1
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	27c247e5-ef93-e9a5-e063-6394a90a2e1e	1
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	1ece23ae-2d7c-d6d7-e063-6394a90ac3b1	1
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	27c247e5-ef93-e9a5-e063-6394a90a2e1e	1
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	1ece23ae-2d7c-d6d7-e063-6394a90ac3b1	1
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	27c247e5-ef93-e9a5-e063-6394a90a2e1e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-515-01	64980051501	1 BOTTLE, PLASTIC in 1 CARTON (64980-515-01) / 10 mL in 1 BOTTLE, PLASTIC	2017-11-01	0000-00-00	No	No	Current
64980-515-05	64980051505	1 BOTTLE, PLASTIC in 1 CARTON (64980-515-05) / 5 mL in 1 BOTTLE, PLASTIC	2017-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Ophthalmic solution USP 0.3%	ST. MARY'S MEDICAL PARK PHARMACY	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	2
Ofloxacin Ophthalmic solution USP 0.3%	A-S Medication Solutions	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	5
Ofloxacin Ophthalmic solution USP 0.3%	REMEDYREPACK INC.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	12
Ofloxacin Ophthalmic solution USP 0.3%	Rising Pharma Holdings, Inc. \| FDC Limited	2025-05-23	HUMAN PRESCRIPTION DRUG LABEL	9
Ofloxacin Ophthalmic solution USP 0.3%	RedPharm Drug	2024-08-03	HUMAN PRESCRIPTION DRUG LABEL	1
Ofloxacin Ophthalmic solution USP 0.3%	Preferred Pharmaceuticals, Inc.	2023-08-17	HUMAN PRESCRIPTION DRUG LABEL	2
Ofloxacin Ophthalmic solution USP 0.3%	REMEDYREPACK INC.	2022-07-12	HUMAN PRESCRIPTION DRUG LABEL	7
Ofloxacin Ophthalmic solution USP 0.3%	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	2
Ofloxacin Ophthalmic solution USP 0.3%	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
Ofloxacin Ophthalmic solution USP 0.3%	Preferred Pharmaceuticals Inc.	2020-08-07	HUMAN PRESCRIPTION DRUG LABEL	5
Ofloxacin Ophthalmic solution USP 0.3%	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	4