NDC 71525-005

Baclofen (intrathecal)

Baclofen

Baclofen (intrathecal) is a Intrathecal Injection in the Human Prescription Drug category. It is labeled and distributed by Emerald International Limited. The primary component is Baclofen.

Product ID71525-005_66d85337-b4ad-403e-8631-3123311477b7
NDC71525-005
Product TypeHuman Prescription Drug
Proprietary NameBaclofen (intrathecal)
Generic NameBaclofen
Dosage FormInjection
Route of AdministrationINTRATHECAL
Marketing Start Date2018-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA091193
Labeler NameEmerald International Limited
Substance NameBACLOFEN
Active Ingredient Strength0 mg/mL
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 71525-005-10

10 AMPULE in 1 BOX (71525-005-10) > 1 mL in 1 AMPULE (71525-005-01)
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71525-005-01 [71525000501]

Baclofen (intrathecal) INJECTION
Marketing CategoryANDA
Application NumberANDA091193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 71525-005-10 [71525000510]

Baclofen (intrathecal) INJECTION
Marketing CategoryANDA
Application NumberANDA091193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN.05 mg/mL

OpenFDA Data

SPL SET ID:63c13374-f4d1-4437-a703-acb8211f2ae4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1666613
  • 308517
  • 308516

    • 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 "Baclofen (intrathecal)" or generic name "Baclofen"

    NDCBrand NameGeneric Name
    71525-040Baclofen (intrathecal)Baclofen (intrathecal)
    71525-010Baclofen (intrathecal)Baclofen (intrathecal)
    71525-005Baclofen (intrathecal)Baclofen (intrathecal)
    70511-124Baclofen (Intrathecal)Baclofen (Intrathecal)
    70511-122Baclofen (Intrathecal)Baclofen (Intrathecal)
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.