NDC 71335-0103

Baclofen

Baclofen

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

Product ID71335-0103_58816b46-28a5-48e2-b89d-98df65939386
NDC71335-0103
Product TypeHuman Prescription Drug
Proprietary NameBaclofen
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA077241
Labeler NameBryant Ranch Prepack
Substance NameBACLOFEN
Active Ingredient Strength20 mg/1
Pharm ClassesGABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-0103-0

120 TABLET in 1 BOTTLE (71335-0103-0)
Marketing Start Date2018-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0103-0 [71335010300]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-10

NDC 71335-0103-6 [71335010306]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

NDC 71335-0103-8 [71335010308]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

NDC 71335-0103-3 [71335010303]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

NDC 71335-0103-7 [71335010307]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

NDC 71335-0103-1 [71335010301]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

NDC 71335-0103-2 [71335010302]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

NDC 71335-0103-4 [71335010304]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

NDC 71335-0103-5 [71335010305]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

NDC 71335-0103-9 [71335010309]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA077241
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-10

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN20 mg/1

OpenFDA Data

SPL SET ID:58816b46-28a5-48e2-b89d-98df65939386
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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