Baclofen

Product NDC
72162-1080
11-digit product format
721621080
Labeler code
72162
Product ID
72162-1080_3bef8995-272b-4e6e-ac32-5d61a3708b22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077241
Marketing category
ANDA
Marketing start
2005-12-20
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
72162-1080-072162108000120 TABLET in 1 BOTTLE, PLASTIC (72162-1080-0) 120 tablet2023-05-08NoNoHistorical
72162-1080-172162108001100 TABLET in 1 BOTTLE, PLASTIC (72162-1080-1) 100 tablet2023-05-08NoNoHistorical
72162-1080-37216210800330 TABLET in 1 BOTTLE, PLASTIC (72162-1080-3) 30 tablet2023-05-08NoNoHistorical
72162-1080-572162108005500 TABLET in 1 BOTTLE, PLASTIC (72162-1080-5) 500 tablet2023-05-08NoNoHistorical
72162-1080-67216210800660 TABLET in 1 BOTTLE, PLASTIC (72162-1080-6) 60 tablet2023-05-08NoNoHistorical
72162-1080-97216210800990 TABLET in 1 BOTTLE, PLASTIC (72162-1080-9) 90 tablet2023-05-08NoNoHistorical

Related DailyMed Labels

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