Moxifloxacin Hydrochloride

Product NDC: 67296-1616
11-digit product format: 672961616
Labeler code: 67296
Product ID: 67296-1616_d61c3e86-1857-9f4c-e053-2a95a90a94fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Moxifloxacin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA202632
Marketing category: ANDA
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: MOXIFLOXACIN HYDROCHLORIDE
Active strength: 400 mg/1
Pharmacologic classes: Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-1616		I	Inactivated by FDA		2026-08-17
excluded package	package	67296-1616	67296-1616-5	I	Inactivated by FDA		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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-1616-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-1616-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67296-1616-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67296-1616-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67296-1616-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67296-1616-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-1616-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-1616-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-1616-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-1616-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-1616-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1616-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1616-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1616-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1616-5	`1332a3947898…`	`d4bfe170f9cd…`

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
A202632-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB		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
A202632-001	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	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202632-001	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	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	2014-03-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202632-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	AB	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	A202632-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202632-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202632-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202632-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202632-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202632-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202632-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202632-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202632-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202632-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202632-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202632-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202632-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202632-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202632-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202632-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202632-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202632-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202632-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202632-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202632-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202632-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202632-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202632-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202632-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202632-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202632-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202632-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202632-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202632-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202632-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202632-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202632-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202632-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202632-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202632-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202632-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202632-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202632-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202632-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1616-5	2024-01-30	C162847	48780-1	1030e365-3be4-111a-e063-dadaa90a10e2	moxifloxacin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1616-5	Moxifloxacin Hydrochloride	5 in 1 BOTTLE	TABLET, FILM COATED	5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1616	MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.]	3	Legacy NDC, 1 package rows	20220122_6cbcf4d7-85c8-f744-e053-2a91aa0a2ae1.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	American Health Packaging	1ed191f5-7df5-488c-bb72-91ac0b618d9a	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	bd0c0690-ba48-41c5-b76b-b1a53c36f424	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	AvPAK	371ca7b2-c62d-ef4b-3076-890b385bfff8	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	be5b7a6f-9ee3-4453-807e-4761fffff60c	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a98b20d-c4a1-4184-8387-a4866d1d62bf	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	18b77b31-baf3-416f-b3b7-a631c8e46d20	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	6cd420c3-113e-4fc2-b59f-bfc7c485c14d	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Major Pharmaceuticals	815d71cf-02de-4190-9bd1-3fdc67ef0f06	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	Bryant Ranch Prepack	ac8a81b9-2fed-412a-8c83-db8dee1061f6	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	f34c08e6-fe74-4de3-9e36-a82c3c1c183b	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	37466c79-8726-4fd6-9412-0bb83d523fe3	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	Aurobindo Pharma Limited	d6789c17-4a2f-4519-9060-e3b0dba422f0	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	REMEDYREPACK INC.	54377276-96bf-4140-9e90-55623ab6b013	2025-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	02c29e8e-8346-4e28-b7fc-2f4cb61ad37d	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	c71e5987-edd7-4c38-b646-3e48a6e51bf4	2023-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202632 application number: ANDA202632

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
311787	moxifloxacin HCl 400 MG Oral Tablet	PSN	6cbcf4d7-85c8-f744-e053-2a91aa0a2ae1	3
311787	moxifloxacin 400 MG Oral Tablet	SCD	6cbcf4d7-85c8-f744-e053-2a91aa0a2ae1	3
311787	moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet	SY	6cbcf4d7-85c8-f744-e053-2a91aa0a2ae1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1616-5	67296161605	5 TABLET, FILM COATED in 1 BOTTLE (67296-1616-5)	2018-01-01	0000-00-00	No	No	Current