NDC 50436-9022

Baclofen

Baclofen

Baclofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Baclofen.

Product ID50436-9022_09d2deae-1b90-4d32-8d8e-390a5e193d18
NDC50436-9022
Product TypeHuman Prescription Drug
Proprietary NameBaclofen
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1988-07-21
Marketing CategoryANDA / ANDA
Application NumberANDA072234
Labeler NameUnit Dose Services
Substance NameBACLOFEN
Active Ingredient Strength10 mg/1
Pharm ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50436-9022-1

30 TABLET in 1 BOTTLE (50436-9022-1)
Marketing Start Date2021-03-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50436-9022-1 [50436902201]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-07-21
Inactivation Date2020-01-31

NDC 50436-9022-3 [50436902203]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-07-21
Inactivation Date2020-01-31

NDC 50436-9022-2 [50436902202]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-07-21
Inactivation Date2020-01-31

NDC 50436-9022-5 [50436902205]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-07-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN10 mg/1

OpenFDA Data

SPL SET ID:ec9c8b7f-9fb0-4274-9532-2fee335c055d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197391

    • 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
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