BACLOFEN

Product NDC
83008-062
11-digit product format
830080062
Labeler code
83008
Product ID
83008-062_ac55cb2c-a5ac-42e1-8a2e-eb810ec7d280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA214099
Marketing category
ANDA
Marketing start
2024-05-21
Marketing end
2027-01-31
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
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
H789N3FKE8BACLOFEN1134-47-0BACLOFEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83008-062-308300800623030 TABLET in 1 BOTTLE (83008-062-30) 30 tablet2024-06-242026-12-31NoNoHistorical
83008-062-908300800629090 TABLET in 1 BOTTLE (83008-062-90) 90 tablet2024-05-212027-01-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Baclofen Tablets USP Rx onlyQuality Care Products, LLC2024-12-19Human Prescription Drug Label4