MOXIFLOXACIN

Product NDC: 61919-553
11-digit product format: 619190553
Labeler code: 61919
Product ID: 61919-553_8385abd7-1529-0d7e-e053-2991aa0ac846
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MOXIFLOXACIN
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: DIRECT RX
Application: ANDA090080
Marketing category: ANDA
Marketing start: 2018-07-30
Marketing end: 0000-00-00
Substance: MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active strength: 5 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	61919-553		I	Inactivated by FDA		2026-08-17
excluded package	package	61919-553	61919-553-05	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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-553-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-553-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-553-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-553-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-553-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-553-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-553-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-553-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-553-05	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A090080-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2017-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090080-001	AT1

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	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090080-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2017-06-30	`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	A090080-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090080-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090080-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090080-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090080-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090080-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090080-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090080-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090080-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090080-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090080-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090080-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090080-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090080-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090080-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090080-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090080-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090080-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090080-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090080-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090080-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090080-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090080-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090080-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090080-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090080-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090080-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090080-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090080-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090080-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090080-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090080-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090080-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090080-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090080-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090080-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090080-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090080-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090080-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090080-001	AT1	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
61919-553-05	2025-01-30	C162847	48780-1	2cef2736-61c8-d83d-e063-dadaa90ab31f	MOXIFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-553-05	MOXIFLOXACIN	3 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	3		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-553-05	ML - Milliliter	61919-553	a7ef0d6e-cb24-43bc-994e-97d73064400d	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-553	MOXIFLOXACIN SOLUTION/ DROPS [DIRECT RX]	1	Legacy NDC, 1 package rows	20190402_723771a2-3e9a-e6f3-e053-2a91aa0a4d21.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin	MOXIFLOXACIN	Golden State Medical Supply, Inc.	f9dff08a-edb2-86de-e053-6394a90a1043	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090080 application number: ANDA090080
Moxifloxacin	MOXIFLOXACIN	Apotex Corp.	8f7a0c4c-34f4-7362-579b-f26c3338f792	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090080 application number: ANDA090080
Moxifloxacin	MOXIFLOXACIN	Advanced Rx Pharmacy of Tennessee, LLC	f19fa89e-9f5d-4eed-e053-2995a90ac3ce	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090080 application number: ANDA090080
Moxifloxacin	MOXIFLOXACIN	Bryant Ranch Prepack	1cc031d7-0766-41c0-b5b3-35119c850e23	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090080 application number: ANDA090080

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B8956S8609	MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE	192927-63-2	MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
U188XYD42P	MOXIFLOXACIN	151096-09-2	MOXIFLOXACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	723771a2-3e9a-e6f3-e053-2a91aa0a4d21	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	723771a2-3e9a-e6f3-e053-2a91aa0a4d21	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	723771a2-3e9a-e6f3-e053-2a91aa0a4d21	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-553-05	61919055305	3 mL in 1 BOTTLE, DROPPER (61919-553-05)	3 ml	2018-07-30	0000-00-00	No	No	Current