NDC 63395-201

Evoxac

Cevimeline Hydrochloride

Evoxac is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Daiichi Sankyo, Inc.. The primary component is Cevimeline Hydrochloride.

Product ID63395-201_0d318261-db69-4064-9e34-5cecb91e8b3c
NDC63395-201
Product TypeHuman Prescription Drug
Proprietary NameEvoxac
Generic NameCevimeline Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2000-01-12
Marketing CategoryNDA / NDA
Application NumberNDA020989
Labeler NameDaiichi Sankyo, Inc.
Substance NameCEVIMELINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
Pharm ClassesCholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 63395-201-13

100 CAPSULE in 1 BOTTLE, PLASTIC (63395-201-13)
Marketing Start Date2000-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63395-201-13 [63395020113]

Evoxac CAPSULE
Marketing CategoryNDA
Application NumberNDA020989
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-01-12

Drug Details

Active Ingredients

IngredientStrength
CEVIMELINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:0679dd4c-fece-4c6d-b273-2c62237e8973
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261361
  • 309140
  • UPC Code
  • 0363395201132
  • Pharmacological Class

    • Cholinergic Muscarinic Agonists [MoA]
    • Cholinergic Receptor Agonist [EPC]

    Medicade Reported Pricing

    63395020113 EVOXAC 30 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Evoxac" or generic name "Cevimeline Hydrochloride"

    NDCBrand NameGeneric Name
    0713-0883Evoxaccevimeline hydrochloride
    63395-201Evoxaccevimeline hydrochloride
    0054-0334Cevimeline HydrochlorideCevimeline Hydrochloride
    0713-0937cevimeline hydrochloridecevimeline hydrochloride
    16571-657Cevimeline HydrochlorideCevimeline Hydrochloride
    40032-999cevimeline hydrochloridecevimeline hydrochloride
    43386-999cevimeline hydrochloridecevimeline hydrochloride

    Trademark Results [Evoxac]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EVOXAC
    EVOXAC
    77641881 3736042 Live/Registered
    DAIICHI SANKYO COMPANY, LIMITED
    2008-12-31
    EVOXAC
    EVOXAC
    75837264 2579509 Live/Registered
    DAIICHI SANKYO COMPANY, LIMITED
    1999-11-01
    EVOXAC
    EVOXAC
    74350561 1980336 Dead/Cancelled
    DAIICHI PHARMACEUTICAL CO., LTD.
    1993-01-19

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