VIGAMOX

Product NDC: 0078-0939
11-digit product format: 000780939
Labeler code: 0078
Product ID: 0078-0939_5f83352b-a62b-4611-8f74-5826d26749a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: moxifloxacin hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Novartis Pharmaceuticals Corporation
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: 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	0078-0939		I	Inactivated by FDA		2026-08-17
excluded package	package	0078-0939	0078-0939-26	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	0078-0939-26	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	0078-0939-26	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	0078-0939-26	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	0078-0939-26	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	0078-0939-26	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	0078-0939-26	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	0078-0939-26	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	0078-0939-26	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	0078-0939-26	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
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
0078-0939-26	2025-01-30	C162847	48780-1	2cef2736-7368-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use VIGAMOX safely and effectively. See full prescribing information for VIGAMOX. VIGAMOX ® (moxifloxacin ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-0939-26	VIGAMOX	1 in 1 CARTON	SOLUTION/ DROPS	1		3
0078-0939-26	VIGAMOX	3 mL in 1 BOTTLE	SOLUTION/ DROPS	3		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0939-26	ML - Milliliter	0078-0939	300c9d1e-988a-465a-b9a9-ed0b00233626	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0939	VIGAMOX (MOXIFLOXACIN HYDROCHLORIDE) SOLUTION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]	3	Legacy NDC, 2 package rows	20230421_ad783689-2b59-448c-b0d6-e8b70cf8b062.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	ad783689-2b59-448c-b0d6-e8b70cf8b062	3
404473	VIGAMOX 0.5 % Ophthalmic Solution	PSN	ad783689-2b59-448c-b0d6-e8b70cf8b062	3
404473	moxifloxacin 5 MG/ML Ophthalmic Solution [Vigamox]	SBD	ad783689-2b59-448c-b0d6-e8b70cf8b062	3
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	ad783689-2b59-448c-b0d6-e8b70cf8b062	3
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	ad783689-2b59-448c-b0d6-e8b70cf8b062	3
404473	Vigamox 0.5 % Ophthalmic Solution	SY	ad783689-2b59-448c-b0d6-e8b70cf8b062	3
404473	Vigamox 5 MG/ML Ophthalmic Solution	SY	ad783689-2b59-448c-b0d6-e8b70cf8b062	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0939-26	00078093926	1 BOTTLE in 1 CARTON (0078-0939-26) > 3 mL in 1 BOTTLE	1 bottle	2021-08-12	0000-00-00	No	No	Current