NDC 0603-2406

Baclofen

Baclofen

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

Product ID0603-2406_03475a8a-17ec-41d9-9740-114a6bd72f56
NDC0603-2406
Product TypeHuman Prescription Drug
Proprietary NameBaclofen
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-08-30
Marketing CategoryANDA / ANDA
Application NumberANDA077156
Labeler NamePar Pharmaceutical
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 Through2020-12-31

Packaging

NDC 0603-2406-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-2406-21)
Marketing Start Date2005-08-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-2406-32 [00603240632]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-08-30

NDC 0603-2406-16 [00603240616]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077156
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-08-30
Marketing End Date2017-10-17

NDC 0603-2406-21 [00603240621]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-08-30

NDC 0603-2406-30 [00603240630]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-08-30
Marketing End Date2017-10-31

NDC 0603-2406-28 [00603240628]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-08-30

NDC 0603-2406-10 [00603240610]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077156
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-08-30
Marketing End Date2017-10-17

NDC 0603-2406-02 [00603240602]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-08-30
Marketing End Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN10 mg/1

OpenFDA Data

SPL SET ID:c17527be-661d-42f5-b6f6-56a681ba7870
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197391
  • 197392
    • UPC Code
  • 0306032407214
  • 0306032406217

    • 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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