Moxifloxacin

Product NDC: 63323-850
Requested package NDC: 63323-850-04
11-digit product format: 633230850
Labeler code: 63323
Product ID: 63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MOXIFLOXACIN HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA205572
Marketing category: NDA
Marketing start: 2015-03-18
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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205572-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-04-03	`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	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
a4e28b09-714b-46e7-b4e6-0163cad78fc5	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
63323-850-04	Moxifloxacin	12 in 1 CASE	INJECTION, SOLUTION	12		7
63323-850-74	Moxifloxacin	250 mL in 1 BAG	INJECTION, SOLUTION	250		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-850-04	ML - Milliliter	63323-850	dbc0f17e-1a29-4069-a7d4-ec188ac06dcd	1	2025-05-14
63323-850-74	ML - Milliliter	63323-850	7f881612-5dc0-48a7-a4fb-ef8a197464c0	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MOXIFLOXACIN HYDROCHLORIDE	ACTIVE INGREDIENT	C53598599T	MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
MOXIFLOXACIN	ACTIVE MOIETY	U188XYD42P	MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM SULFATE	INACTIVE INGREDIENT	0YPR65R21J	MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-850	MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	7	Current NDC, Legacy NDC, 2 package rows	20240509_a4e28b09-714b-46e7-b4e6-0163cad78fc5.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
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 ndc (package): 63323-850-04 ndc (product): 63323-850 ndc11 (package): 63323085004

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	a4e28b09-714b-46e7-b4e6-0163cad78fc5	7
351156	250 ML moxifloxacin 1.6 MG/ML Injection	SCD	a4e28b09-714b-46e7-b4e6-0163cad78fc5	7
351156	moxifloxacin 400 MG per 250 ML Injection	SY	a4e28b09-714b-46e7-b4e6-0163cad78fc5	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63323-850-04	63323085004	12 BAG in 1 CASE (63323-850-04) / 250 mL in 1 BAG (63323-850-74)	12 bag	2015-03-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Moxifloxacin	Fresenius Kabi USA, LLC \| HP Halden Pharma AS	2024-05-06	HUMAN PRESCRIPTION DRUG LABEL	7