Moxifloxacin

Product NDC: 63629-8357
11-digit product format: 636298357
Labeler code: 63629
Product ID: 63629-8357_27864513-a113-4ec1-9e78-41bc762172bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Moxifloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076938
Marketing category: ANDA
Marketing start: 2014-03-05
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
A076938-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076938-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2014-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2014-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		2014-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076938-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	RS	2014-03-04	`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	A076938-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076938-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076938-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076938-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076938-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076938-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076938-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076938-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076938-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076938-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076938-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076938-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076938-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076938-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076938-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076938-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076938-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076938-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076938-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076938-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076938-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076938-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076938-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076938-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076938-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076938-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076938-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076938-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076938-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076938-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076938-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076938-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076938-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076938-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076938-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076938-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076938-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076938-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076938-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076938-001	AB	1	`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/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
d20ba997-30de-445c-8766-924112bd834a	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
63629-8357-1	Moxifloxacin	7 in 1 BOTTLE	TABLET, FILM COATED	7		104
63629-8357-2	Moxifloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10		104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8357	MOXIFLOXACIN (MOXIFLOXACIN) TABLET, FILM COATED [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 2 package rows	20231109_d20ba997-30de-445c-8766-924112bd834a.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	MOXIFLOXACIN	PD-Rx Pharmaceuticals, Inc.	1c6f7150-a8f4-408f-956f-c26d37030cf4	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076938 application number: ANDA076938
Moxifloxacin	MOXIFLOXACIN	Bryant Ranch Prepack	d20ba997-30de-445c-8766-924112bd834a	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076938 application number: ANDA076938 ndc (product): 63629-8357
Moxifloxacin	MOXIFLOXACIN	Dr. Reddy's Laboratories Limited	71b02da1-3175-1db8-192a-c0a8a6cd98a5	2020-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076938 application number: ANDA076938

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	d20ba997-30de-445c-8766-924112bd834a	104
311787	moxifloxacin 400 MG Oral Tablet	SCD	d20ba997-30de-445c-8766-924112bd834a	104
311787	moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet	SY	d20ba997-30de-445c-8766-924112bd834a	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8357-1	63629835701	7 TABLET, FILM COATED in 1 BOTTLE (63629-8357-1)	2020-09-17	0000-00-00	No	No	Current
63629-8357-2	63629835702	10 TABLET, FILM COATED in 1 BOTTLE (63629-8357-2)	2020-11-05	0000-00-00	No	No	Current