Vigabatrin for oral solution USP, 500 mg

Product NDC
0054-0702
11-digit product format
000540702
Labeler code
0054
Product ID
0054-0702_aa195953-19b3-88b1-e053-2995a90a714b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vigabatrin
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA213469
Marketing category
ANDA
Marketing start
2020-07-10
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0702-190005407021950 PACKET in 1 CARTON (0054-0702-19) > 10 mL in 1 PACKET50 packet2020-07-100000-00-00NoNoCurrent