VIGAFYDE

Product NDC: 80789-003
11-digit product format: 807890003
Labeler code: 80789
Product ID: 80789-003_43aeb38a-b4ee-47ed-8239-c488b074f1c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vigabatrin
Dosage form: SOLUTION
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: NDA217684
Marketing category: NDA
Marketing start: 2024-06-18
Substance: VIGABATRIN
Active strength: 100 mg/mL
Pharmacologic classes: Anti-epileptic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
N217684-001	VIGAFYDE	VIGABATRIN	100MG/ML	SOLUTION / ORAL		RLD, RS	2024-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N217684-001	12016857	2039-08-16	Drug product	2024-07-01
N217684-001	12290499	2042-10-17	Drug product	2025-05-13
N217684-001	12576054	2043-06-08	Drug product	2026-03-23

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217684-001	VIGAFYDE	100MG/ML	SOLUTION / ORAL	RLD, RS	2024-06-17	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217684-001	12290499	2042-10-17	Drug product	2025-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217684-001	12576054	2043-06-08	Drug product	2026-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217684-001	12290499	2042-10-17	Drug product	2025-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217684-001	12290499	2042-10-17	Drug product	2025-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217684-001	12290499	2042-10-17	Drug product	2025-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217684-001	12016857	2039-08-16	Drug product	2024-07-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217684-001	12290499	2042-10-17	Drug product	2025-05-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217684-001	12576054	2043-06-08	Drug product	2026-03-23	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: VIGAFYDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VIGABATRIN	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GR120KRT6K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2685217	Internal RxNorm lookup
2685223	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
8d3d6316-33ab-41e8-9485-4495c218be56	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
096748f0-965a-4afd-a326-9f691a2861e8	Product name	1	20250224
9dea3de0-6f03-9477-9f83-4ffb0883e43f	Product name	6	20240507
9a8c6108-e754-40ae-a629-36a466ae0079	Product name	8	20230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80789-003-15	VIGAFYDE	150 mL in 1 BOTTLE	SOLUTION	150		19
80789-003-15	VIGAFYDE	1 in 1 CARTON	SOLUTION	1		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80789-003-15	ML - Milliliter	80789-003	731ce48e-d5ae-4bf7-ac23-429d6f9939e9	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80789-003	VIGAFYDE (VIGABATRIN) SOLUTION [UPSHER-SMITH LABORATORIES, LLC]	14	Current NDC, 2 package rows	20250522_8d3d6316-33ab-41e8-9485-4495c218be56.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VIGAFYDE	VIGABATRIN	Upsher-Smith Laboratories, LLC	8d3d6316-33ab-41e8-9485-4495c218be56	2025-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217684 application number: NDA217684 ndc (product): 80789-003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GR120KRT6K	VIGABATRIN	68506-86-5	VIGABATRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2685217	vigabatrin 100 MG in 1 mL Concentrate for Oral Solution	PSN	8d3d6316-33ab-41e8-9485-4495c218be56	19
2685223	VIGAFYDE 100 MG in 1 mL Concentrate for Oral Solution	PSN	8d3d6316-33ab-41e8-9485-4495c218be56	19
2685223	vigabatrin 100 MG/ML Oral Solution [Vigafyde]	SBD	8d3d6316-33ab-41e8-9485-4495c218be56	19
2685217	vigabatrin 100 MG/ML Oral Solution	SCD	8d3d6316-33ab-41e8-9485-4495c218be56	19
2685217	vigabatrin 100 MG per 1 ML Concentrate for Oral Solution	SY	8d3d6316-33ab-41e8-9485-4495c218be56	19
2685223	Vigafyde 100 MG per 1 ML Concentrate for Oral Solution	SY	8d3d6316-33ab-41e8-9485-4495c218be56	19
2685223	Vigafyde 100 MG/ML Oral Solution	SY	8d3d6316-33ab-41e8-9485-4495c218be56	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80789-003-15	80789000315	1 BOTTLE in 1 CARTON (80789-003-15) / 150 mL in 1 BOTTLE	1 bottle	2024-08-26	No	No	Current