Moxifloxacin

Product NDC: 31722-845
11-digit product format: 317220845
Labeler code: 31722
Product ID: 31722-845_40b874c7-8b88-6a93-e063-6394a90ad44f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Moxifloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA204836
Marketing category: ANDA
Marketing start: 2023-03-02
Substance: MOXIFLOXACIN HYDROCHLORIDE
Active strength: 400 mg/1
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
A204836-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2023-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204836-001	AB

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.

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	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204836-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2023-03-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204836-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204836-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204836-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204836-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204836-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204836-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204836-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204836-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204836-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204836-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204836-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204836-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204836-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204836-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204836-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204836-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204836-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204836-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204836-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204836-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204836-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204836-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204836-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204836-001	AB	1	`a50c72e98297…`

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/1

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
311787	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
1e6bc886-eec9-4cd8-be78-7563817457f2	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
31722-845-05	Moxifloxacin	500 in 1 BOTTLE	TABLET, FILM COATED	500		4
31722-845-30	Moxifloxacin	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-845	MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	3	Current NDC, 2 package rows	20230316_1e6bc886-eec9-4cd8-be78-7563817457f2.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	Camber Pharmaceuticals, Inc.	1e6bc886-eec9-4cd8-be78-7563817457f2	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204836 application number: ANDA204836 ndc (product): 31722-845

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
311787	moxifloxacin HCl 400 MG Oral Tablet	PSN	1e6bc886-eec9-4cd8-be78-7563817457f2	4
311787	moxifloxacin 400 MG Oral Tablet	SCD	1e6bc886-eec9-4cd8-be78-7563817457f2	4
311787	moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet	SY	1e6bc886-eec9-4cd8-be78-7563817457f2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
31722-845-05	31722084505	500 TABLET, FILM COATED in 1 BOTTLE (31722-845-05)	2023-03-02	No	No	Current
31722-845-30	31722084530	30 TABLET, FILM COATED in 1 BOTTLE (31722-845-30)	2023-03-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Moxifloxacin	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit V	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	4