NDC 69528-301

OZOBAX

Baclofen

OZOBAX is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Metacel Pharmaceuticals, Llc. The primary component is Baclofen.

Product ID69528-301_853dcc09-d7a7-46e7-b2d6-7d440e82dae7
NDC69528-301
Product TypeHuman Prescription Drug
Proprietary NameOZOBAX
Generic NameBaclofen
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-09-18
Marketing CategoryNDA / NDA
Application NumberNDA208193
Labeler NameMetacel Pharmaceuticals, LLC
Substance NameBACLOFEN
Active Ingredient Strength5 mg/5mL
Pharm ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69528-301-16

473 mL in 1 BOTTLE (69528-301-16)
Marketing Start Date2019-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69528-301-16 [69528030116]

OZOBAX SOLUTION
Marketing CategoryNDA
Application NumberNDA208193
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-18

Drug Details

Active Ingredients

IngredientStrength
BACLOFEN5 mg/5mL

OpenFDA Data

SPL SET ID:92153f69-bc9b-4bef-9a8e-751effde5c7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 250976
  • 2201578

    • 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 "OZOBAX" or generic name "Baclofen"

    NDCBrand NameGeneric Name
    69528-301OZOBAXOZOBAX
    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 [OZOBAX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OZOBAX
    OZOBAX
    88071622 not registered Live/Pending
    Metacel Pharmaceuticals LLC
    2018-08-09
    OZOBAX
    OZOBAX
    86372981 not registered Dead/Abandoned
    Metacel Pharmaceuticals LLC
    2014-08-21
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