Baclofen

Product NDC
68788-6384
11-digit product format
687886384
Labeler code
68788
Product ID
68788-6384_672a5bd7-8403-4173-af80-25c659d17dac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077241
Marketing category
ANDA
Marketing start
2016-05-04
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
20 mg/1
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-6384-3EA - Each68788-6384f3ff20f8-143f-4984-8c87-b6ecda5ba5f112020-05-08
68788-6384-6EA - Each68788-6384f664a262-b806-44b1-bb4e-3d32fda8064b12020-05-08
68788-6384-8EA - Each68788-6384192425b1-2fb6-4727-bab7-530e76926b4c12020-05-08
68788-6384-9EA - Each68788-6384a800c441-6cc3-446f-b2d7-9d6818c9555212020-05-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-6384-168788638401100 TABLET in 1 BOTTLE, PLASTIC (68788-6384-1) 100 tablet2016-05-040000-00-00NoNoCurrent
68788-6384-36878863840330 TABLET in 1 BOTTLE, PLASTIC (68788-6384-3) 30 tablet2016-05-040000-00-00NoNoCurrent
68788-6384-66878863840660 TABLET in 1 BOTTLE, PLASTIC (68788-6384-6) 60 tablet2016-05-040000-00-00NoNoCurrent
68788-6384-868788638408120 TABLET in 1 BOTTLE, PLASTIC (68788-6384-8) 120 tablet2016-05-040000-00-00NoNoCurrent
68788-6384-96878863840990 TABLET in 1 BOTTLE, PLASTIC (68788-6384-9) 90 tablet2016-05-040000-00-00NoNoCurrent