MOXIFLOXACIN

Product NDC: 72189-321
11-digit product format: 721890321
Labeler code: 72189
Product ID: 72189-321_2c3d2dfe-0fff-b986-e063-6294a90a84c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MOXIFLOXACIN
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Direct Rx
Application: ANDA202867
Marketing category: ANDA
Marketing start: 2022-02-07
Substance: MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
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

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-321-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-321-05	`0efc9e666f02…`	`f202fb6c5f17…`

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
A202867-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2014-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202867-001	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.

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	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202867-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202867-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202867-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202867-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202867-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202867-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202867-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202867-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202867-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202867-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202867-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202867-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202867-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202867-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202867-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202867-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202867-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202867-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202867-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202867-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202867-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202867-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202867-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202867-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202867-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202867-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202867-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202867-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202867-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202867-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202867-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202867-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202867-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202867-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202867-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202867-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202867-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202867-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202867-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202867-001	AT1	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: MOXIFLOXACIN
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B8956S8609	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
d771e69b-7d9b-13fa-e053-2995a90ac161	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
72189-321-05	MOXIFLOXACIN	3 mL in 1 BOTTLE	SOLUTION/ DROPS	3		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-321	MOXIFLOXACIN SOLUTION/ DROPS [DIRECT RX]	2	Current NDC, Legacy NDC, 1 package rows	20250122_d771e69b-7d9b-13fa-e053-2995a90ac161.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin	MOXIFLOXACIN	Redpharm Drug	301eef74-16db-14aa-e063-6294a90ac8ff	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867
Moxifloxacin	MOXIFLOXACIN	Lupin Pharmaceuticals, Inc.	ae77e219-8af9-4aa4-96d3-05c9726a1d3c	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867
MOXIFLOXACIN	MOXIFLOXACIN	Direct Rx	d771e69b-7d9b-13fa-e053-2995a90ac161	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867 ndc (product): 72189-321
Moxifloxacin	MOXIFLOXACIN	Advanced Rx Pharmacy of Tennessee, LLC	143075b4-24d4-08a1-e063-6394a90a8a6e	2024-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867
Moxifloxacin	MOXIFLOXACIN	A-S Medication Solutions	4dee7a26-25e2-4ce9-8fd2-e8c3ac6ef5ff	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B8956S8609	MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE	192927-63-2	MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
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	d771e69b-7d9b-13fa-e053-2995a90ac161	2
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	d771e69b-7d9b-13fa-e053-2995a90ac161	2
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	d771e69b-7d9b-13fa-e053-2995a90ac161	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-321-05	72189032105	3 mL in 1 BOTTLE (72189-321-05)	3 ml	2022-02-07	0000-00-00	No	No	Current