Baclofen

Product NDC
71335-2826
11-digit product format
713352826
Labeler code
71335
Product ID
71335-2826_5a714497-fb1c-4f1b-93bc-b21c907a5b1c
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
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
71335-2826-171335282601100 TABLET in 1 BOTTLE (71335-2826-1) 100 tablet2025-10-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Baclofen Tablets, USP Rx onlyBryant Ranch Prepack2025-11-12HUMAN PRESCRIPTION DRUG LABEL101