Vigabatrin

Product NDC: 64850-940
Requested package NDC: 64850-940-50
11-digit product format: 648500940
Labeler code: 64850
Product ID: 64850-940_e5351b0d-e810-41f1-b56f-18245bbf43a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vigabatrin
Dosage form: FOR SOLUTION
Route: ORAL
Labeler: Elite Laboratories, Inc.
Application: ANDA214961
Marketing category: ANDA
Marketing start: 2022-06-24
Marketing end: 0000-00-00
Substance: VIGABATRIN
Active strength: 50 mg/mL
Pharmacologic classes: Anti-epileptic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64850-940	64850-940-50	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A214961-001	VIGPODER	VIGABATRIN	500MG/PACKET	FOR SOLUTION / ORAL	AA		2022-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214961-001	AA

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A214961-001	VIGPODER	500MG/PACKET	FOR SOLUTION / ORAL	AA		2022-06-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A214961-001	AA	1	`a50c72e98297…`

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64850-940-50	64850094050	50 PACKET in 1 CARTON (64850-940-50) > 10 mL in 1 PACKET (64850-940-01)	50 packet	2022-06-24	0000-00-00	No	No	Current