Baclofen

Product NDC
72162-1079
11-digit product format
721621079
Labeler code
72162
Product ID
72162-1079_5de12657-b943-4215-8979-d2a285fcd7ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078220
Marketing category
ANDA
Marketing start
2007-07-01
Substance
BACLOFEN
Active strength
10 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
72162-1079-0721621079001000 TABLET in 1 BOTTLE, PLASTIC (72162-1079-0) 1000 tablet2023-05-08NoNoHistorical
72162-1079-172162107901100 TABLET in 1 BOTTLE, PLASTIC (72162-1079-1) 100 tablet2023-05-08NoNoHistorical
72162-1079-872162107908140 TABLET in 1 BOTTLE, PLASTIC (72162-1079-8) 140 tablet2023-05-08NoNoHistorical
72162-1079-97216210790990 TABLET in 1 BOTTLE, PLASTIC (72162-1079-9) 90 tablet2023-05-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Baclofen Tablets, USPBryant Ranch Prepack2024-01-30HUMAN PRESCRIPTION DRUG LABEL101