Vigabatrin for oral solution USP, 500 mg

Product NDC
70010-083
11-digit product format
700100083
Labeler code
70010
Product ID
70010-083_d11d4f4e-2254-8af8-e053-2995a90ac77d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vigabatrin
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA213469
Marketing category
ANDA
Marketing start
2022-06-15
Marketing end
0000-00-00
Substance
VIGABATRIN
Active strength
500 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-083-457001000834550 FOR SOLUTION in 1 PACKET (70010-083-45) 50 for solution2022-06-150000-00-00NoNoCurrent