NDC 30698-419

EQUETRO

Carbamazepine

EQUETRO is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Validus Pharmaceuticals Llc. The primary component is Carbamazepine.

Product ID30698-419_414a3f25-2360-4b36-875c-90ec4e5a2dfa
NDC30698-419
Product TypeHuman Prescription Drug
Proprietary NameEQUETRO
Generic NameCarbamazepine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2004-12-10
Marketing CategoryNDA / NDA
Application NumberNDA021710
Labeler NameValidus Pharmaceuticals LLC
Substance NameCARBAMAZEPINE
Active Ingredient Strength100 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 30698-419-12

120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-419-12)
Marketing Start Date2004-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 30698-419-12 [30698041912]

EQUETRO CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-12-10

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE100 mg/1

OpenFDA Data

SPL SET ID:be478f3c-40f6-47cc-8ab9-f420a9372b1c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 672908
  • 672909
  • 200133
  • 388311
  • 200131
  • 672910
  • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Mood Stabilizer [EPC]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 1A2 Inducers [MoA]
    • Cytochrome P450 2B6 Inducers [MoA]
    • Cytochrome P450 2C9 Inducers [MoA]
    • Cytochrome P450 2C19 Inducers [MoA]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Mood Stabilizer [EPC]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 1A2 Inducers [MoA]
    • Cytochrome P450 2B6 Inducers [MoA]
    • Cytochrome P450 2C9 Inducers [MoA]
    • Cytochrome P450 2C19 Inducers [MoA]

    NDC Crossover Matching brand name "EQUETRO" or generic name "Carbamazepine"

    NDCBrand NameGeneric Name
    30698-423EQUETROEQUETRO
    30698-419EQUETROEQUETRO
    30698-421EQUETROEQUETRO
    0093-0109CarbamazepineCarbamazepine
    0093-0778CarbamazepineCarbamazepine
    0093-0090EpitolCarbamazepine
    0078-0508Tegretolcarbamazepine
    0078-0509Tegretolcarbamazepine
    0078-0510Tegretolcarbamazepine
    0078-0511Tegretolcarbamazepine
    0078-0512Tegretolcarbamazepine

    Trademark Results [EQUETRO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EQUETRO
    EQUETRO
    78527735 3155034 Live/Registered
    VALIDUS PHARMACEUTICALS LLC
    2004-12-06

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