Baclofen

Product NDC
71335-2392
11-digit product format
713352392
Labeler code
71335
Product ID
71335-2392_a8fc5ccd-16f4-4cb1-a422-f49efddf6adb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212067
Marketing category
ANDA
Marketing start
2020-07-09
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
71335-2392-071335239200112 TABLET in 1 BOTTLE (71335-2392-0) 112 tablet2024-05-29NoNoHistorical
71335-2392-17133523920130 TABLET in 1 BOTTLE (71335-2392-1) 30 tablet2024-05-29NoNoHistorical
71335-2392-271335239202120 TABLET in 1 BOTTLE (71335-2392-2) 120 tablet2024-05-29NoNoHistorical
71335-2392-37133523920320 TABLET in 1 BOTTLE (71335-2392-3) 20 tablet2024-05-29NoNoHistorical
71335-2392-47133523920460 TABLET in 1 BOTTLE (71335-2392-4) 60 tablet2024-05-29NoNoHistorical
71335-2392-571335239205100 TABLET in 1 BOTTLE (71335-2392-5) 100 tablet2024-05-29NoNoHistorical
71335-2392-67133523920656 TABLET in 1 BOTTLE (71335-2392-6) 56 tablet2024-05-29NoNoHistorical
71335-2392-77133523920790 TABLET in 1 BOTTLE (71335-2392-7) 90 tablet2024-05-29NoNoHistorical
71335-2392-871335239208140 TABLET in 1 BOTTLE (71335-2392-8) 140 tablet2024-05-29NoNoHistorical
71335-2392-97133523920984 TABLET in 1 BOTTLE (71335-2392-9) 84 tablet2024-05-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BaclofenBryant Ranch Prepack2024-08-16HUMAN PRESCRIPTION DRUG LABEL2