NDC 58281-562

Lioresal

Baclofen

Lioresal is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Medtronic Neuromodulation. The primary component is Baclofen.

Product ID58281-562_824b1807-be48-4239-bfdc-2d1d15b42c71
NDC58281-562
Product TypeHuman Prescription Drug
Proprietary NameLioresal
Generic NameBaclofen
Dosage FormInjection
Route of AdministrationINTRATHECAL
Marketing Start Date1996-11-07
Marketing CategoryNDA / NDA
Application NumberNDA020075
Labeler NameMedtronic Neuromodulation
Substance NameBACLOFEN
Active Ingredient Strength0 mg/mL
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 58281-562-01

1 AMPULE in 1 CARTON (58281-562-01) > 1 mL in 1 AMPULE
Marketing Start Date1996-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58281-562-01 [58281056201]

Lioresal INJECTION
Marketing CategoryNDA
Application NumberNDA020075
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-11-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN.05 mg/mL

OpenFDA Data

SPL SET ID:351cde63-00fa-404a-92df-cb055e991840
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805678
  • 805679
  • 1666620
  • 1666622
  • 1666623
  • 1666613
  • 308517
  • 308516

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Lioresal" or generic name "Baclofen"

    NDCBrand NameGeneric Name
    58281-560LioresalLioresal
    58281-562LioresalLioresal
    58281-563LioresalLioresal
    58281-561LioresalLioresal
    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

    Trademark Results [Lioresal]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LIORESAL
    LIORESAL
    85215266 4006164 Live/Registered
    SAOL INTERNATIONAL LIMITED
    2011-01-11
    LIORESAL
    LIORESAL
    72307555 0877316 Dead/Expired
    CIBA LIMITED
    1968-09-17
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.