Tetrabenazine

Product NDC
68180-409
11-digit product format
681800409
Labeler code
68180
Product ID
68180-409_c936ac22-98a5-4025-ae04-b98fb9dee08e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetrabenazine
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA210544
Marketing category
ANDA
Marketing start
2018-11-19
Marketing end
0000-00-00
Substance
TETRABENAZINE
Active strength
25 mg/1
Pharmacologic classes
Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-409-58EA - Each68180-409fc33bf78-9d17-4498-b914-bf94c87654ed12018-12-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-409-5868180040958112 TABLET in 1 BOTTLE (68180-409-58) 112 tablet2018-11-190000-00-00NoNoCurrent