NDC 61919-095

BACLOFEN

Baclofen

BACLOFEN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Baclofen.

Product ID61919-095_34286c4a-e4bd-27d0-e054-00144ff8d46c
NDC61919-095
Product TypeHuman Prescription Drug
Proprietary NameBACLOFEN
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA077241
Labeler NameDIRECT RX
Substance NameBACLOFEN
Active Ingredient Strength20 mg/1
Pharm ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-095-30

30 TABLET in 1 BOTTLE (61919-095-30)
Marketing Start Date2019-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-095-86 [61919009586]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-29

NDC 61919-095-60 [61919009560]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-29
Inactivation Date2020-01-31

NDC 61919-095-30 [61919009530]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-29

NDC 61919-095-90 [61919009590]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-04-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN20 mg/1

OpenFDA Data

SPL SET ID:7d164f22-a8d8-4ad1-9ea2-f29cc73b7ec8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197392

    • Pharmacological Class

    • GABA A Agonists [MoA]
    • GABA B Agonists [MoA]
    • gamma-Aminobutyric Acid-ergic Agonist [EPC]

    NDC Crossover Matching brand name "BACLOFEN" or generic name "Baclofen"

    NDCBrand NameGeneric Name
    0115-1010BaclofenBaclofen
    0115-1011BaclofenBaclofen
    0115-1012BaclofenBaclofen
    0172-4096BaclofenBaclofen
    0172-4097BaclofenBaclofen
    0527-1330Baclofenbaclofen
    0527-1333Baclofenbaclofen
    0527-1337Baclofenbaclofen
    0603-2406BaclofenBaclofen
    0603-2407BaclofenBaclofen
    0615-3541BaclofenBaclofen
    0615-3542BaclofenBaclofen
    0615-8411BaclofenBaclofen
    0615-8412BaclofenBaclofen
    68071-3075BaclofenBaclofen
    68071-3001BaclofenBaclofen
    68084-855BaclofenBaclofen
    68084-868BaclofenBaclofen
    68788-0522BaclofenBaclofen
    68788-6903BaclofenBaclofen
    68788-9246BaclofenBaclofen
    68788-6384BaclofenBaclofen
    68788-9735BaclofenBaclofen
    68788-9796BaclofenBaclofen
    68788-9846BaclofenBaclofen
    70518-0215BaclofenBaclofen
    70518-0362BaclofenBaclofen
    70518-0411BaclofenBaclofen
    70518-0547BaclofenBaclofen
    70518-1515BaclofenBaclofen
    70710-1285BaclofenBaclofen
    70771-1449BaclofenBaclofen
    70771-1448BaclofenBaclofen
    70710-1286BaclofenBaclofen
    71335-0206BaclofenBaclofen
    71335-0344BaclofenBaclofen
    71335-0103BaclofenBaclofen
    71335-0949BACLOFENBACLOFEN
    0832-1025BaclofenBaclofen
    0832-1055BaclofenBaclofen
    0832-1024BaclofenBaclofen
    0832-1054BaclofenBaclofen
    0904-5222BaclofenBaclofen
    0904-3365BaclofenBaclofen
    0904-6476BaclofenBaclofen
    0904-6475BaclofenBaclofen
    10135-533BaclofenBaclofen
    10135-532BaclofenBaclofen
    10544-172BaclofenBaclofen
    16714-072BaclofenBaclofen
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.