Baclofen

Product NDC
71335-2482
11-digit product format
713352482
Labeler code
71335
Product ID
71335-2482_84fa949b-42d8-4fd9-b38d-f408eaa2657e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212378
Marketing category
ANDA
Marketing start
2024-06-15
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
71335-2482-17133524820160 TABLET in 1 BOTTLE (71335-2482-1) 60 tablet2024-09-03NoNoHistorical
71335-2482-271335248202120 TABLET in 1 BOTTLE (71335-2482-2) 120 tablet2024-09-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Baclofen Tablets, USP Rx onlyBryant Ranch Prepack2024-09-03HUMAN PRESCRIPTION DRUG LABEL1