Baclofen

Product NDC
68788-7635
11-digit product format
687887635
Labeler code
68788
Product ID
68788-7635_d4a7905a-c689-4c15-b97a-48101e433022
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211555
Marketing category
ANDA
Marketing start
2020-03-06
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7635-1EA - Each68788-763541405009-c946-436d-ac0c-db49190bd6de12020-04-20
68788-7635-3EA - Each68788-7635246d6c4f-2948-4bd5-99df-ce57c10f290012020-04-20
68788-7635-6EA - Each68788-763554c34c98-9897-4179-9bd7-4431ef4d3de212020-04-20
68788-7635-8EA - Each68788-76356d04a622-0ada-471a-aa93-d9a99763dc9a12020-04-20
68788-7635-9EA - Each68788-763536331e9a-1df0-4aea-a3d6-4234ba2fd7f812020-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7635-168788763501100 TABLET in 1 BOTTLE (68788-7635-1) 100 tablet2020-03-060000-00-00NoNoCurrent
68788-7635-368788763503100 TABLET in 1 BOTTLE (68788-7635-3) 100 tablet2020-03-060000-00-00NoNoCurrent
68788-7635-66878876350660 TABLET in 1 BOTTLE (68788-7635-6) 60 tablet2020-03-060000-00-00NoNoCurrent
68788-7635-868788763508120 TABLET in 1 BOTTLE (68788-7635-8) 120 tablet2020-03-060000-00-00NoNoCurrent
68788-7635-96878876350990 TABLET in 1 BOTTLE (68788-7635-9) 90 tablet2020-03-060000-00-00NoNoCurrent