VIGAMOX

Product NDC: 21695-968
11-digit product format: 216950968
Labeler code: 21695
Product ID: 21695-968_68cca7e1-120c-4ac6-8851-15a17e11bd9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: moxifloxacin hydrochloride
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Rebel Distributors Corp
Application: NDA021598
Marketing category: NDA
Marketing start: 2003-05-07
Marketing end: 0000-00-00
Substance: MOXIFLOXACIN HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-968		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-968	21695-968-03	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 · 44 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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`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	21695-968-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-968-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-968-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-968-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-968-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-968-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-968-03	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-968-03	`110d247fa046…`	`a55b01930146…`

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
N021598-001	VIGAMOX	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021598-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021598-001	VIGAMOX	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	2003-04-15	`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	N021598-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021598-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021598-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021598-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021598-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021598-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021598-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021598-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021598-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021598-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021598-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021598-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021598-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021598-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021598-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021598-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021598-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021598-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021598-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021598-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021598-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021598-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021598-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021598-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021598-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021598-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021598-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021598-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021598-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021598-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021598-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021598-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021598-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021598-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021598-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021598-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021598-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021598-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021598-001	AT1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021598-001	AT1	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021598-001	6716830	2019-09-29		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021598-001	7671070	2019-09-29	U-709		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021598-001	6716830	2019-09-29		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021598-001	7671070	2019-09-29	U-709		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021598-001	6716830	2019-09-29		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021598-001	7671070	2019-09-29	U-709		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021598-001	6716830	2019-09-29		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021598-001	7671070	2019-09-29	U-709		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021598-001	6716830*PED	2020-03-29		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021598-001	7671070*PED	2020-03-29		Pediatric extension	`ea99ee380514…`

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
21695-968-03	2019-09-24	C162847	48780-1	934fe258-4971-48b1-e053-8cdaa90a720a	VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% as base

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-968-03	VIGAMOX	3 mL in 1 BOTTLE, PLASTIC	SOLUTION	3		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-968-03	ML - Milliliter	21695-968	ddb6a236-b949-4daa-93f1-8e6ffe32a390	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MOXIFLOXACIN HYDROCHLORIDE	ACTIVE INGREDIENT	C53598599T	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
MOXIFLOXACIN	ACTIVE MOIETY	U188XYD42P	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-968	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110914_68cca7e1-120c-4ac6-8851-15a17e11bd9f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VIGAMOX	MOXIFLOXACIN HYDROCHLORIDE	Harrow Eye, LLC	12053b08-7e66-c6f3-e063-6394a90a9cd9	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021598 application number: NDA021598
Moxifloxacin Ophthalmic Solution	MOXIFLOXACIN HYDROCHLORIDE	Sandoz Inc	fc88791b-24da-48a4-85f5-93a8af3d0b51	2020-06-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021598 application number: NDA021598

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
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	68cca7e1-120c-4ac6-8851-15a17e11bd9f	1
404473	VIGAMOX 0.5 % Ophthalmic Solution	PSN	68cca7e1-120c-4ac6-8851-15a17e11bd9f	1
404473	moxifloxacin 5 MG/ML Ophthalmic Solution [Vigamox]	SBD	68cca7e1-120c-4ac6-8851-15a17e11bd9f	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	68cca7e1-120c-4ac6-8851-15a17e11bd9f	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	68cca7e1-120c-4ac6-8851-15a17e11bd9f	1
404473	Vigamox 0.5 % Ophthalmic Solution	SY	68cca7e1-120c-4ac6-8851-15a17e11bd9f	1
404473	Vigamox 5 MG/ML Ophthalmic Solution	SY	68cca7e1-120c-4ac6-8851-15a17e11bd9f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-968-03	21695096803	3 mL in 1 BOTTLE, PLASTIC	3 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% as base	Rebel Distributors Corp	2011-09-13	HUMAN PRESCRIPTION DRUG LABEL	1