NDC 52959-733

Baclofen

Baclofen

Baclofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Baclofen.

Product ID52959-733_0d3ec116-a621-4f15-bc56-c63487a319bc
NDC52959-733
Product TypeHuman Prescription Drug
Proprietary NameBaclofen
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA072234
Labeler NameH.J. Harkins Company, Inc.
Substance NameBACLOFEN
Active Ingredient Strength10 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 52959-733-30

30 TABLET in 1 BOTTLE (52959-733-30)
Marketing Start Date2010-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-733-90 [52959073390]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-60 [52959073360]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-30 [52959073330]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-40 [52959073340]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-12 [52959073312]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-20 [52959073320]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-00 [52959073300]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-18 [52959073318]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-10 [52959073310]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

NDC 52959-733-02 [52959073302]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-15
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN10 mg/1

OpenFDA Data

SPL SET ID:962601f8-7567-4afe-90a0-6df356f5a297
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197391
  • 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
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