BACLOFEN

Product NDC
71335-2219
11-digit product format
713352219
Labeler code
71335
Product ID
71335-2219_a61f8df2-6383-497b-93b0-70b1da356068
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214099
Marketing category
ANDA
Marketing start
2021-07-13
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
71335-2219-071335221900120 TABLET in 1 BOTTLE (71335-2219-0) 120 tablet2023-08-15NoNoHistorical
71335-2219-17133522190190 TABLET in 1 BOTTLE (71335-2219-1) 90 tablet2023-08-15NoNoHistorical
71335-2219-27133522190220 TABLET in 1 BOTTLE (71335-2219-2) 20 tablet2023-08-15NoNoHistorical
71335-2219-37133522190360 TABLET in 1 BOTTLE (71335-2219-3) 60 tablet2023-08-15NoNoHistorical
71335-2219-47133522190445 TABLET in 1 BOTTLE (71335-2219-4) 45 tablet2023-08-15NoNoHistorical
71335-2219-571335221905112 TABLET in 1 BOTTLE (71335-2219-5) 112 tablet2023-08-15NoNoHistorical
71335-2219-67133522190630 TABLET in 1 BOTTLE (71335-2219-6) 30 tablet2023-08-15NoNoHistorical
71335-2219-77133522190756 TABLET in 1 BOTTLE (71335-2219-7) 56 tablet2023-08-15NoNoHistorical
71335-2219-87133522190815 TABLET in 1 BOTTLE (71335-2219-8) 15 tablet2023-08-15NoNoHistorical
71335-2219-97133522190984 TABLET in 1 BOTTLE (71335-2219-9) 84 tablet2023-08-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Baclofen Tablets USP Rx onlyBryant Ranch Prepack2025-08-25HUMAN PRESCRIPTION DRUG LABEL104