Moxifloxacin

Product NDC: 68180-422
11-digit product format: 681800422
Labeler code: 68180
Product ID: 68180-422_40262fef-9713-4538-b96b-c44b257d6a25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Moxifloxacin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA202867
Marketing category: ANDA
Marketing start: 2017-07-01
Substance: MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
Active strength: 5 mg/mL
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
A202867-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2014-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202867-001	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	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`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	A202867-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202867-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202867-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202867-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202867-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202867-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202867-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202867-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202867-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202867-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202867-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202867-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202867-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202867-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202867-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202867-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202867-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202867-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202867-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202867-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202867-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202867-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202867-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202867-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202867-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202867-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202867-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202867-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202867-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202867-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202867-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202867-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202867-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202867-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202867-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202867-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202867-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202867-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202867-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202867-001	AT1	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 MONOHYDRATE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B8956S8609	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403818	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
ae77e219-8af9-4aa4-96d3-05c9726a1d3c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3fecff3-fb51-4f66-b443-a130905bb500	Product name	1	20250804
e42b5738-f3b2-36cb-547c-d658794618bc	Product name	2	20250804
84b851da-be59-d750-14d1-e4d93cc3b4da	Product name	9	20250630
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
6a38bd75-79e3-96c0-1204-08a0282902ae	Product name	4	20250128
4ce8f27b-067c-45ad-b8f6-4b29ec66e497	Product name	2	20250115
b81a1117-443d-49e4-a709-58c3c32468af	Product name	5	20241010
4d6e22a5-3693-6edf-0179-2ab93aecbadb	Product name	9	20240724
2194a6ab-15bb-de49-cced-f09e642b1b64	Product name	8	20240313
03452e68-2506-686e-a908-f2381c778fc6	Product name	5	20240307
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
ee6f8cae-1597-1a7e-3fb9-6aaeba954efe	Product name	3	20150902
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
d7840f4c-f22a-4403-b5da-53ac6ac8fd90	Product name	1	20150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531b	Product name	2	20150611
8442aba0-7521-47cb-8a4e-c9896f35e8ae	Product name	3	20150317
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
18d57d04-4a34-a130-5dd5-b7fc47f3b567	Product name	1	20140508
379bc253-901a-e6e1-92b7-0fc574249e07	Product name	1	20140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68180-422-01	Moxifloxacin	1 in 1 CARTON	SOLUTION/ DROPS	1		9
68180-422-01	Moxifloxacin	3 mL in 1 BOTTLE	SOLUTION/ DROPS	3		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-422-01	ML - Milliliter	68180-422	e6bd441f-79e7-4e7a-9f6c-87d36199ac00	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-422	MOXIFLOXACIN SOLUTION/ DROPS [LUPIN PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250221_ae77e219-8af9-4aa4-96d3-05c9726a1d3c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin	MOXIFLOXACIN	Redpharm Drug	301eef74-16db-14aa-e063-6294a90ac8ff	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867
Moxifloxacin	MOXIFLOXACIN	Lupin Pharmaceuticals, Inc.	ae77e219-8af9-4aa4-96d3-05c9726a1d3c	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867 ndc (product): 68180-422
MOXIFLOXACIN	MOXIFLOXACIN	Direct Rx	d771e69b-7d9b-13fa-e053-2995a90ac161	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867
Moxifloxacin	MOXIFLOXACIN	Advanced Rx Pharmacy of Tennessee, LLC	143075b4-24d4-08a1-e063-6394a90a8a6e	2024-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867
Moxifloxacin	MOXIFLOXACIN	A-S Medication Solutions	4dee7a26-25e2-4ce9-8fd2-e8c3ac6ef5ff	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202867 application number: ANDA202867

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	ae77e219-8af9-4aa4-96d3-05c9726a1d3c	9
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	ae77e219-8af9-4aa4-96d3-05c9726a1d3c	9
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	ae77e219-8af9-4aa4-96d3-05c9726a1d3c	9
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	4dee7a26-25e2-4ce9-8fd2-e8c3ac6ef5ff	5
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	4dee7a26-25e2-4ce9-8fd2-e8c3ac6ef5ff	5
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	4dee7a26-25e2-4ce9-8fd2-e8c3ac6ef5ff	5
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	301eef74-16db-14aa-e063-6294a90ac8ff	4
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	301eef74-16db-14aa-e063-6294a90ac8ff	4
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	301eef74-16db-14aa-e063-6294a90ac8ff	4
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	d771e69b-7d9b-13fa-e053-2995a90ac161	2
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	d771e69b-7d9b-13fa-e053-2995a90ac161	2
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	d771e69b-7d9b-13fa-e053-2995a90ac161	2
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
578018	bromfenac 0.09 % Ophthalmic Solution	PSN	2df9064c-0527-4c21-e063-6294a90a56d8	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	143075b4-24d4-08a1-e063-6394a90a8a6e	1
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	2df9064c-0527-4c21-e063-6294a90a56d8	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	2df9064c-0527-4c21-e063-6294a90a56d8	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
578018	bromfenac 0.9 MG/ML Ophthalmic Solution	SCD	2df9064c-0527-4c21-e063-6294a90a56d8	1
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	2df9064c-0527-4c21-e063-6294a90a56d8	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	143075b4-24d4-08a1-e063-6394a90a8a6e	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	2df9064c-0527-4c21-e063-6294a90a56d8	1
578018	bromfenac 0.09 % Ophthalmic Solution	SY	2df9064c-0527-4c21-e063-6294a90a56d8	1
578018	bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic Solution	SY	2df9064c-0527-4c21-e063-6294a90a56d8	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	2df9064c-0527-4c21-e063-6294a90a56d8	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	143075b4-24d4-08a1-e063-6394a90a8a6e	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	249b0f15-9c13-90e2-e063-6394a90a1fd5	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	2df9064c-0527-4c21-e063-6294a90a56d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-422-01	68180042201	1 BOTTLE in 1 CARTON (68180-422-01) / 3 mL in 1 BOTTLE	1 bottle	2017-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Moxifloxacin	Redpharm Drug	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	4
Moxifloxacin	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	9
STRENZA PLUS	Brisk Pharmaceuticals	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	1
Moxifloxacin	Direct Rx	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
STRENZA	Brisk Pharmaceuticals	2024-10-16	HUMAN PRESCRIPTION DRUG LABEL	1
Moxifloxacin	Advanced Rx Pharmacy of Tennessee, LLC	2024-03-21	HUMAN PRESCRIPTION DRUG LABEL	1
Moxifloxacin	A-S Medication Solutions	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL	5
IXOBA M	Brisk Pharmaceuticals, Inc. \| Unit Dose Solutions, Inc	2021-11-03	HUMAN PRESCRIPTION DRUG LABEL	2