Moxifloxacin Ophthalmic Solution

Product NDC: 72266-158
Requested package NDC: 72266-158-01
11-digit product format: 722660158
Labeler code: 72266
Product ID: 72266-158_3a227739-e57d-10aa-e063-6294a90ac95e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Moxifloxacin Ophthalmic
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Fosun Pharma USA Inc.
Application: ANDA208778
Marketing category: ANDA
Marketing start: 2020-08-24
Substance: MOXIFLOXACIN HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [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
A208778-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2020-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208778-001	AT1

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	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208778-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2020-03-30	`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	A208778-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208778-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208778-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208778-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208778-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208778-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208778-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208778-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208778-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208778-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208778-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208778-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208778-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208778-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208778-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208778-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208778-001	AT1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208778-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208778-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208778-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208778-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208778-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208778-001	AT1	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208778-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208778-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208778-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208778-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208778-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208778-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208778-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208778-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208778-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208778-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208778-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208778-001	AT1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208778-001	AT1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208778-001	AT1	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Moxifloxacin Ophthalmic Solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MOXIFLOXACIN HYDROCHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C53598599T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403818	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
9eae534a-9253-4a45-9ab7-2543626f49e6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
84b851da-be59-d750-14d1-e4d93cc3b4da	Product name	9	20250630
2194a6ab-15bb-de49-cced-f09e642b1b64	Product name	8	20240313
d7840f4c-f22a-4403-b5da-53ac6ac8fd90	Product name	1	20150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531b	Product name	2	20150611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72266-158-01	Moxifloxacin Ophthalmic Solution	1 in 1 CARTON	SOLUTION/ DROPS	1		3
72266-158-01	Moxifloxacin Ophthalmic Solution	3 mL in 1 BOTTLE	SOLUTION/ DROPS	3		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72266-158	MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN OPHTHALMIC) SOLUTION/ DROPS [FOSUN PHARMA USA INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240518_9eae534a-9253-4a45-9ab7-2543626f49e6.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
Moxifloxacin Ophthalmic Solution	MOXIFLOXACIN OPHTHALMIC	Fosun Pharma USA Inc.	9eae534a-9253-4a45-9ab7-2543626f49e6	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208778 application number: ANDA208778 ndc (package): 72266-158-01 ndc (product): 72266-158 ndc11 (package): 72266015801
Moxifloxacin Ophthalmic	MOXIFLOXACIN OPHTHALMIC	A-S Medication Solutions	c76f7d78-1e52-4557-a43b-cfc8e5842c80	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208778 application number: ANDA208778
Moxifloxacin Ophthalmic Solution	MOXIFLOXACIN OPHTHALMIC	Gland Pharma Limited	95773bca-0791-4bfe-955a-4d2fa4561e01	2020-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208778 application number: ANDA208778

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C53598599T	MOXIFLOXACIN HYDROCHLORIDE	186826-86-8	MOXIFLOXACIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	9eae534a-9253-4a45-9ab7-2543626f49e6	3
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	c76f7d78-1e52-4557-a43b-cfc8e5842c80	3
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	9eae534a-9253-4a45-9ab7-2543626f49e6	3
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	c76f7d78-1e52-4557-a43b-cfc8e5842c80	3
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	9eae534a-9253-4a45-9ab7-2543626f49e6	3
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	c76f7d78-1e52-4557-a43b-cfc8e5842c80	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72266-158-01	72266015801	1 BOTTLE in 1 CARTON (72266-158-01) / 3 mL in 1 BOTTLE	1 bottle	2020-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Moxifloxacin Ophthalmic Solution	Fosun Pharma USA Inc.	2023-12-17	HUMAN PRESCRIPTION DRUG LABEL	3
Moxifloxacin Ophthalmic	A-S Medication Solutions	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	3