NDC 52817-321

BACLOFEN

Baclofen

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

Product ID52817-321_96d56088-7b3d-3960-e053-2a95a90a8e04
NDC52817-321
Product TypeHuman Prescription Drug
Proprietary NameBACLOFEN
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA209102
Labeler NameTruPharma LLC
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 Through2020-12-31

Packaging

NDC 52817-321-00

1000 TABLET in 1 BOTTLE (52817-321-00)
Marketing Start Date2018-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52817-321-50 [52817032150]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA209102
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-01

NDC 52817-321-10 [52817032110]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA209102
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-01

NDC 52817-321-00 [52817032100]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA209102
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-01

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN20 mg/1

OpenFDA Data

SPL SET ID:68aa591e-ea98-4438-9a4a-4f7e9ea2b285
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 430902
  • 197391
  • 197392
  • UPC Code
  • 0352817321107
  • Pharmacological Class

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

    Medicade Reported Pricing

    52817032110 BACLOFEN 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    52817032100 BACLOFEN 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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