Baclofen

Product NDC
63187-274
11-digit product format
631870274
Labeler code
63187
Product ID
63187-274_8ef3522a-3a22-4d52-852d-a18f5a78f482
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA072235
Marketing category
ANDA
Marketing start
1988-07-21
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
63187-274-306318702743030 TABLET in 1 BOTTLE (63187-274-30) 30 tablet2014-11-21NoNoHistorical
63187-274-606318702746060 TABLET in 1 BOTTLE (63187-274-60) 60 tablet2014-11-21NoNoHistorical
63187-274-906318702749090 TABLET in 1 BOTTLE (63187-274-90) 90 tablet2014-11-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BACLOFEN TABLETS USP Rx onlyProficient Rx LP2024-10-01HUMAN PRESCRIPTION DRUG LABEL5