MOXIFLOXACIN

Product NDC: 68180-421
11-digit product format: 681800421
Labeler code: 68180
Product ID: 68180-421_29272b83-77cf-4cd1-9aed-b80d0cc6edb5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MOXIFLOXACIN
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA204079
Marketing category: ANDA
Marketing start: 2020-02-13
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
A204079-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2015-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204079-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT2		2015-05-28	`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	A204079-001	AT2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204079-001	AT2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204079-001	AT2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204079-001	AT2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204079-001	AT2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204079-001	AT2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204079-001	AT2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204079-001	AT2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204079-001	AT2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204079-001	AT2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204079-001	AT2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204079-001	AT2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204079-001	AT2	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204079-001	AT2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204079-001	AT2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204079-001	AT2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204079-001	AT2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204079-001	AT2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204079-001	AT2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204079-001	AT2	1	`cb3db0bc1861…`

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
d66f080b-da56-4473-8785-920d9700f72d	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
68180-421-01	MOXIFLOXACIN	3 mL in 1 BOTTLE	SOLUTION	3		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-421-01	ML - Milliliter	68180-421	97952939-54eb-4db0-82aa-e8833eee8ae6	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-421	MOXIFLOXACIN SOLUTION [LUPIN PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250210_d66f080b-da56-4473-8785-920d9700f72d.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	Lupin Pharmaceuticals, Inc.	d66f080b-da56-4473-8785-920d9700f72d	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204079 application number: ANDA204079 ndc (product): 68180-421

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	d66f080b-da56-4473-8785-920d9700f72d	7
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	d66f080b-da56-4473-8785-920d9700f72d	7
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	d66f080b-da56-4473-8785-920d9700f72d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-421-01	68180042101	3 mL in 1 BOTTLE (68180-421-01)	3 ml	2020-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MOXIFLOXACIN	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	7