NDC 70257-563

Lioresal (baclofen)

Baclofen

Lioresal (baclofen) is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Saol Therapeutics Inc.. The primary component is Baclofen.

Product ID70257-563_2f1776d9-60a5-4b9c-83a3-6fb4b717a3cd
NDC70257-563
Product TypeHuman Prescription Drug
Proprietary NameLioresal (baclofen)
Generic NameBaclofen
Dosage FormInjection
Route of AdministrationINTRATHECAL
Marketing Start Date2022-01-03
Marketing CategoryNDA / NDA
Application NumberNDA020075
Labeler NameSaol Therapeutics Inc.
Substance NameBACLOFEN
Active Ingredient Strength40 mg/20mL
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 70257-563-01

1 AMPULE in 1 BOX (70257-563-01) > 20 mL in 1 AMPULE (70257-563-20)
Marketing Start Date2022-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70257-563-01 [70257056301]

Lioresal (baclofen) INJECTION
Marketing CategoryNDA
Application NumberNDA020075
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-05

NDC 70257-563-02 [70257056302]

Lioresal (baclofen) INJECTION
Marketing CategoryNDA
Application NumberNDA020075
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-05

NDC 70257-563-20 [70257056320]

Lioresal (baclofen) INJECTION
Marketing CategoryNDA
Application NumberNDA020075
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-05

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN40 mg/20mL

OpenFDA Data

SPL SET ID:4e478edb-e340-4976-ac24-4bb32c5e12e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805678
  • 805679
  • 1666620
  • 1666622
  • 1666623
  • 1666613
  • 308517
  • 308516
  • UPC Code
  • 0049100007533
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Lioresal (baclofen)" or generic name "Baclofen"

    NDCBrand NameGeneric Name
    70257-560Lioresal (baclofen)Lioresal (baclofen)
    70257-563Lioresal (baclofen)Lioresal (baclofen)
    70257-562Lioresal (baclofen)Lioresal (baclofen)
    70257-561Lioresal (baclofen)Lioresal (baclofen)
    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

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