Moxifloxacin

Product NDC: 17478-519
Requested package NDC: 17478-519-19
11-digit product format: 174780519
Labeler code: 17478
Product ID: 17478-519_ac59ac51-425b-4bbd-bb9b-17950a9701b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Moxifloxacin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: ANDA202916
Marketing category: ANDA
Marketing start: 2017-11-09
Marketing end: 0000-00-00
Substance: MOXIFLOXACIN HYDROCHLORIDE
Active strength: 5 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	17478-519	17478-519-19	I	Inactivated by FDA		2026-08-17

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 42.

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
A202916-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC			2017-11-09

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 · 42 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
2026-08-18 06:07:40	2026-07	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202916-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-11-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202916-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202916-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202916-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202916-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202916-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202916-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202916-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202916-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202916-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202916-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202916-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202916-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202916-001	AT1	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A202916-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202916-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202916-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202916-001	AT1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202916-001	AT1	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-519-19	2024-01-30	C162847	48780-1	1030e365-1e3e-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use MOXIFLOXACIN OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for MOXIFLOXACIN OPHTHALMIC SOLUTION. MOXIFLOXACIN ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-519-19	Moxifloxacin	1 in 1 CARTON	SOLUTION/ DROPS	1		4
17478-519-19	Moxifloxacin	3 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	3		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-519-19	ML - Milliliter	17478-519	2352e498-78f4-4fb8-a472-bcb6228c2260	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-519	MOXIFLOXACIN SOLUTION/ DROPS [AKORN]	4	Legacy NDC, 2 package rows	20220203_7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MOXIFLOXACIN	MOXIFLOXACIN	Direct Rx	d9b6a460-6377-76d0-e053-2995a90a3d05	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202916 application number: ANDA202916

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C53598599T	MOXIFLOXACIN HYDROCHLORIDE	186826-86-8	MOXIFLOXACIN HYDROCHLORIDE
U188XYD42P	MOXIFLOXACIN	151096-09-2	Moxifloxacin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08	4
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08	4
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	7ae6355d-aaa3-48e4-a3d5-50f7ca8dfe08	4
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	d9b6a460-6377-76d0-e053-2995a90a3d05	2
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	d9b6a460-6377-76d0-e053-2995a90a3d05	2
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	d9b6a460-6377-76d0-e053-2995a90a3d05	2
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	ccc845e1-0a90-4c74-8659-4d798d8cf752	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	ccc845e1-0a90-4c74-8659-4d798d8cf752	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	ccc845e1-0a90-4c74-8659-4d798d8cf752	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-519-19	17478051919	1 BOTTLE, DROPPER in 1 CARTON (17478-519-19) > 3 mL in 1 BOTTLE, DROPPER	2017-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MOXIFLOXACIN OPTH SOLN 0.5% 3ML	Direct Rx	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
Moxifloxacin	Akorn \| Akorn Operating Company LLC	2021-11-30	HUMAN PRESCRIPTION DRUG LABEL	4
Moxifloxacin	A-S Medication Solutions	2021-01-15	HUMAN PRESCRIPTION DRUG LABEL	1