Moxifloxacin

Product NDC: 66298-8507
11-digit product format: 662988507
Labeler code: 66298
Product ID: 66298-8507_1d783072-b073-e384-e063-6394a90a7460
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MOXIFLOXACIN HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hp Halden Pharma AS
Application: NDA205572
Marketing category: NDA
Marketing start: 2017-08-02
Substance: MOXIFLOXACIN HYDROCHLORIDE
Active strength: 400 mg/250mL
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
N205572-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-04-03

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`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	400 mg/250mL

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
351156	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
6067b2ee-2171-49bb-aa07-1d401ebf4f2e	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
d7840f4c-f22a-4403-b5da-53ac6ac8fd90	Product name	1	20150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531b	Product name	2	20150611
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66298-8507-4	Moxifloxacin	250 mL in 1 BAG	INJECTION, SOLUTION	250		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66298-8507	MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [HP HALDEN PHARMA AS]	4	Current NDC, Legacy NDC, 1 package rows	20240719_6067b2ee-2171-49bb-aa07-1d401ebf4f2e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin	MOXIFLOXACIN HYDROCHLORIDE	Hp Halden Pharma AS	6067b2ee-2171-49bb-aa07-1d401ebf4f2e	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205572 application number: NDA205572 ndc (product): 66298-8507
Moxifloxacin	MOXIFLOXACIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	a4e28b09-714b-46e7-b4e6-0163cad78fc5	2024-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205572 application number: NDA205572

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
351156	moxifloxacin 400 MG in 250 ML Injection	PSN	6067b2ee-2171-49bb-aa07-1d401ebf4f2e	4
351156	250 ML moxifloxacin 1.6 MG/ML Injection	SCD	6067b2ee-2171-49bb-aa07-1d401ebf4f2e	4
351156	moxifloxacin 400 MG per 250 ML Injection	SY	6067b2ee-2171-49bb-aa07-1d401ebf4f2e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66298-8507-4	66298850704	250 mL in 1 BAG (66298-8507-4)	250 ml	2017-08-02	0000-00-00	No	No	Current