Moxifloxacin Hydrochloride Tablets, 400 mg

Product NDC: 69539-006
11-digit product format: 695390006
Labeler code: 69539
Product ID: 69539-006_b58ce71b-fdf0-436d-9592-83b423a71deb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Moxifloxacin Hydrochloride Tablets, 400 mg
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA208682
Marketing category: ANDA
Marketing start: 2017-09-22
Marketing end: 0000-00-00
Substance: MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active strength: 400 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69539-006		D	Discontinued by firm	2026-08-17
excluded package	package	69539-006	69539-006-05	D	Discontinued by firm	2026-08-17
excluded package	package	69539-006	69539-006-30	D	Discontinued by firm	2026-08-17
excluded package	package	69539-006	69539-006-31	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	69539-006-30
excluded package	package	69539-006-05
excluded package	package	69539-006-31

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
A208682-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2017-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208682-001	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.

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	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208682-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2017-09-22	`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	A208682-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208682-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208682-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208682-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208682-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208682-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208682-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208682-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208682-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208682-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208682-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208682-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208682-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208682-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208682-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208682-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208682-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208682-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208682-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208682-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208682-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208682-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208682-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208682-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208682-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208682-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208682-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208682-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208682-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208682-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208682-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208682-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208682-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208682-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208682-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208682-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208682-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208682-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208682-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208682-001	AB	1	`e64feba35796…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-006	MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]	9	Legacy NDC	20240829_92305e3e-7f15-4a30-a6c9-11be6992f8e0.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin Hydrochloride Tablets, 400 mg	MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG	REMEDYREPACK INC.	bdb3f89a-01e7-411d-b071-48e87def0873	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208682 application number: ANDA208682
Moxifloxacin Hydrochloride Tablets, 400 mg	MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG	PD-Rx Pharmaceuticals, Inc.	5c2a9116-d6e4-429e-88bb-bb6bfedac2f0	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208682 application number: ANDA208682
Moxifloxacin Hydrochloride Tablets, 400 mg	MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG	Novadoz Pharmaceuticals LLC	04e0936f-2248-48e4-8031-ac6ccc2df294	2019-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208682 application number: ANDA208682

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B8956S8609	MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE	192927-63-2	MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-006-05	69539000605	500 TABLET, FILM COATED in 1 BOTTLE (69539-006-05)		2019-04-16	0000-00-00	No	No	Current
69539-006-30	69539000630	30 TABLET, FILM COATED in 1 BOTTLE (69539-006-30)		2019-04-16	0000-00-00	No	No	Current
69539-006-31	69539000631	50 BLISTER PACK in 1 CARTON (69539-006-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK (69539-006-11)	50 blister pack	2019-04-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Moxifloxacin Hydrochloride Tablets, 400 mg	MSN LABORATORIES PRIVATE LIMITED	2024-08-28	Human Prescription Drug Label	9