Vigabatrin

Product NDC
68180-521
11-digit product format
681800521
Labeler code
68180
Product ID
68180-521_c79d0642-29bb-47b6-8672-f0210e7782b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vigabatrin
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA211790
Marketing category
ANDA
Marketing start
2022-03-10
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
096748f0-965a-4afd-a326-9f691a2861e8Product name120250224
9dea3de0-6f03-9477-9f83-4ffb0883e43fProduct name620240507
9a8c6108-e754-40ae-a629-36a466ae0079Product name820230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-521-50Vigabatrin50 in 1 CARTONPOWDER, FOR SOLUTION5010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-521VIGABATRIN POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS, INC.]10Legacy NDC, 1 package rows20221202_7585b972-9b38-4bd0-9e72-193454cbc34e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250820vigabatrin 500 MG Powder for Oral SolutionPSN7585b972-9b38-4bd0-9e72-193454cbc34e10
250820vigabatrin 500 MG Powder for Oral SolutionSCD7585b972-9b38-4bd0-9e72-193454cbc34e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-521-506818005215050 POWDER, FOR SOLUTION in 1 CARTON (68180-521-50) 2022-03-100000-00-00NoNoCurrent