NDC 0615-3541

Baclofen

Baclofen

Baclofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The primary component is Baclofen.

Product ID0615-3541_2ed52df2-0435-4344-8754-0d4c53e88f7d
NDC0615-3541
Product TypeHuman Prescription Drug
Proprietary NameBaclofen
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-07-15
Marketing End Date2023-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA072234
Labeler NameNCS HealthCare of KY, LLC dba Vangard Labs
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

Packaging

NDC 0615-3541-05

15 TABLET in 1 BLISTER PACK (0615-3541-05)
Marketing Start Date2015-08-26
Marketing End Date2023-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-3541-31 [00615354131]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-07-15
Marketing End Date2016-07-31

NDC 0615-3541-39 [00615354139]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-07-15

NDC 0615-3541-05 [00615354105]

Baclofen TABLET
Marketing CategoryANDA
Application NumberANDA072234
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-26

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN10 mg/1

OpenFDA Data

SPL SET ID:37d6a465-acde-4acc-9cb5-f5a32b75c072
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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