Baclofen

Product NDC
63629-1224
11-digit product format
636291224
Labeler code
63629
Product ID
63629-1224_cb120481-fba7-4801-8760-6999aeffa4b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212378
Marketing category
ANDA
Marketing start
2020-10-09
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
63629-1224-1636291224011000 TABLET in 1 BOTTLE (63629-1224-1) 1000 tablet2020-10-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Baclofen Tablets, USP Rx onlyBryant Ranch Prepack2024-04-02HUMAN PRESCRIPTION DRUG LABEL104