BACLOFEN

Product NDC
71335-9759
11-digit product format
713359759
Labeler code
71335
Product ID
71335-9759_6e78ab9d-0fb9-449a-81ed-a2f9324601ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACLOFEN
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214374
Marketing category
ANDA
Marketing start
2021-07-01
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
71335-9759-071335975900112 TABLET in 1 BOTTLE (71335-9759-0) 112 tablet2023-08-11NoNoHistorical
71335-9759-17133597590130 TABLET in 1 BOTTLE (71335-9759-1) 30 tablet2023-08-11NoNoHistorical
71335-9759-271335975902120 TABLET in 1 BOTTLE (71335-9759-2) 120 tablet2023-08-11NoNoHistorical
71335-9759-37133597590320 TABLET in 1 BOTTLE (71335-9759-3) 20 tablet2023-08-11NoNoHistorical
71335-9759-47133597590460 TABLET in 1 BOTTLE (71335-9759-4) 60 tablet2023-08-11NoNoHistorical
71335-9759-571335975905100 TABLET in 1 BOTTLE (71335-9759-5) 100 tablet2023-08-11NoNoHistorical
71335-9759-67133597590656 TABLET in 1 BOTTLE (71335-9759-6) 56 tablet2023-08-11NoNoHistorical
71335-9759-77133597590790 TABLET in 1 BOTTLE (71335-9759-7) 90 tablet2023-08-11NoNoHistorical
71335-9759-871335975908140 TABLET in 1 BOTTLE (71335-9759-8) 140 tablet2023-08-11NoNoHistorical
71335-9759-97133597590984 TABLET in 1 BOTTLE (71335-9759-9) 84 tablet2023-08-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BACLOFEN TABLETS USP Rx onlyBryant Ranch Prepack2023-08-11HUMAN PRESCRIPTION DRUG LABEL100