Baclofen

Product NDC
63629-2131
11-digit product format
636292131
Labeler code
63629
Product ID
63629-2131_b6f69948-b8a2-4003-ac12-a6ff124fe3cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077068
Marketing category
ANDA
Marketing start
2005-08-30
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
H789N3FKE8BACLOFEN1134-47-0BACLOFEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-2131-163629213101100 TABLET in 1 BOTTLE, PLASTIC (63629-2131-1) 100 tablet2005-08-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BACLOFEN TABLETS, USPBryant Ranch Prepack2024-12-05HUMAN PRESCRIPTION DRUG LABEL104