Baclofen

Product NDC
71335-9681
11-digit product format
713359681
Labeler code
71335
Product ID
71335-9681_b63760e4-d4d2-47a9-ac83-a08352a16435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077068
Marketing category
ANDA
Marketing start
2005-08-30
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
71335-9681-071335968100120 TABLET in 1 BOTTLE, PLASTIC (71335-9681-0) 120 tablet2024-12-12NoNoHistorical
71335-9681-17133596810190 TABLET in 1 BOTTLE, PLASTIC (71335-9681-1) 90 tablet2024-12-12NoNoHistorical
71335-9681-27133596810220 TABLET in 1 BOTTLE, PLASTIC (71335-9681-2) 20 tablet2024-12-12NoNoHistorical
71335-9681-37133596810360 TABLET in 1 BOTTLE, PLASTIC (71335-9681-3) 60 tablet2024-12-12NoNoHistorical
71335-9681-47133596810445 TABLET in 1 BOTTLE, PLASTIC (71335-9681-4) 45 tablet2024-12-12NoNoHistorical
71335-9681-571335968105112 TABLET in 1 BOTTLE, PLASTIC (71335-9681-5) 112 tablet2024-12-12NoNoHistorical
71335-9681-67133596810630 TABLET in 1 BOTTLE, PLASTIC (71335-9681-6) 30 tablet2024-12-12NoNoHistorical
71335-9681-77133596810756 TABLET in 1 BOTTLE, PLASTIC (71335-9681-7) 56 tablet2024-12-12NoNoHistorical
71335-9681-87133596810815 TABLET in 1 BOTTLE, PLASTIC (71335-9681-8) 15 tablet2024-12-12NoNoHistorical
71335-9681-97133596810984 TABLET in 1 BOTTLE, PLASTIC (71335-9681-9) 84 tablet2024-12-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BACLOFEN TABLETS, USPBryant Ranch Prepack2024-12-12HUMAN PRESCRIPTION DRUG LABEL101