NDC 61919-027

BACLOFEN

Baclofen

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

Product ID61919-027_40f9338f-41b0-19a8-e054-00144ff8d46c
NDC61919-027
Product TypeHuman Prescription Drug
Proprietary NameBACLOFEN
Generic NameBaclofen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA072235
Labeler NameDirect Rx
Substance NameBACLOFEN
Active Ingredient Strength20 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 61919-027-90

90 BOTTLE in 1 BOTTLE (61919-027-90) > 60 BOTTLE in 1 BOTTLE (61919-027-60) > 30 TABLET in 1 BOTTLE (61919-027-30)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-027-60 [61919002760]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA072235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-01

NDC 61919-027-30 [61919002730]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA072235
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-027-90 [61919002790]

BACLOFEN TABLET
Marketing CategoryANDA
Application NumberANDA072235
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN20 mg/1

OpenFDA Data

SPL SET ID:19ec8066-f0e7-4f80-b596-abe7b1ad92cb
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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