MOXIFLOXACIN

Product NDC: 82804-055
11-digit product format: 828040055
Labeler code: 82804
Product ID: 82804-055_c38e051f-5765-4066-9953-2d0832481b1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MOXIFLOXACIN
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Proficient Rx LP
Application: ANDA206242
Marketing category: ANDA
Marketing start: 2017-10-04
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 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
A206242-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2017-10-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206242-001	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	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206242-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-10-04	`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	A206242-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206242-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206242-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206242-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206242-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206242-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206242-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206242-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206242-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206242-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206242-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206242-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206242-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206242-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206242-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206242-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206242-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206242-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206242-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206242-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206242-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206242-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206242-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206242-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206242-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206242-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206242-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206242-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206242-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206242-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206242-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206242-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206242-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206242-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206242-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206242-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206242-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206242-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206242-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206242-001	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	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
c38e051f-5765-4066-9953-2d0832481b1e	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
82804-055-03	MOXIFLOXACIN	3 mL in 1 BOTTLE	SOLUTION/ DROPS	3		1
82804-055-03	MOXIFLOXACIN	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-055-03	ML - Milliliter	82804-055	d8f1f3a1-a18e-43c8-a483-330f3e42094a	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-055	MOXIFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP]	1	Current NDC, 2 package rows	20240112_c38e051f-5765-4066-9953-2d0832481b1e.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
MOXIFLOXACIN	MOXIFLOXACIN	A-S Medication Solutions	f702e112-b037-4e50-ac30-b1d27fc0e30e	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206242 application number: ANDA206242
MOXIFLOXACIN	MOXIFLOXACIN	Aurobindo Pharma Limited	8877013d-9b49-40f7-a2c4-99bb519e104e	2024-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206242 application number: ANDA206242
MOXIFLOXACIN	MOXIFLOXACIN	Proficient Rx LP	c38e051f-5765-4066-9953-2d0832481b1e	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206242 application number: ANDA206242 ndc (product): 82804-055
MOXIFLOXACIN	MOXIFLOXACIN	NorthStar Rx LLC	cdc0b0eb-5f56-45c7-b9fd-364752a95ff1	2022-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206242 application number: ANDA206242

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	c38e051f-5765-4066-9953-2d0832481b1e	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	c38e051f-5765-4066-9953-2d0832481b1e	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	c38e051f-5765-4066-9953-2d0832481b1e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-055-03	82804005503	1 BOTTLE in 1 CARTON (82804-055-03) / 3 mL in 1 BOTTLE	1 bottle	2024-01-09	No	No	Current