NDC 55289-612

Zanaflex

Tizanidine Hydrochloride

Zanaflex is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Tizanidine Hydrochloride.

Product ID55289-612_7c341b25-cc3d-1c4b-e053-2991aa0abb4c
NDC55289-612
Product TypeHuman Prescription Drug
Proprietary NameZanaflex
Generic NameTizanidine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1997-01-01
Marketing CategoryNDA / NDA
Application NumberNDA020397
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameTIZANIDINE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-612-10

10 TABLET in 1 BOTTLE, PLASTIC (55289-612-10)
Marketing Start Date2012-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-612-20 [55289061220]

Zanaflex TABLET
Marketing CategoryNDA
Application NumberNDA020397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-09
Marketing End Date2020-09-30

NDC 55289-612-10 [55289061210]

Zanaflex TABLET
Marketing CategoryNDA
Application NumberNDA020397
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-09
Marketing End Date2020-09-30

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:338c33be-9578-40e8-bdff-64b4e1b74a2c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 153735
  • 313413
    • UPC Code
  • 0355289612100

    • Pharmacological Class

    • Adrenergic alpha2-Agonists [MoA]
    • Central alpha-2 Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "Zanaflex" or generic name "Tizanidine Hydrochloride"

    NDCBrand NameGeneric Name
    10144-594Zanaflextizanidine hydrochloride
    10144-602Zanaflextizanidine hydrochloride
    10144-604Zanaflextizanidine hydrochloride
    10144-606Zanaflextizanidine hydrochloride
    21695-373Zanaflextizanidine hydrochloride
    70515-594ZanaflexZanaflex
    70515-604ZanaflexZanaflex
    70515-602ZanaflexZanaflex
    70515-606ZanaflexZanaflex
    55289-612ZanaflexZanaflex
    80425-0022ZanaflexZanaflex
    80425-0024ZanaflexZanaflex
    80425-0090ZanaflexZanaflex
    80425-0023ZanaflexZanaflex
    0185-0034tizanidine hydrochloridetizanidine hydrochloride
    0185-4400tizanidine hydrochloridetizanidine hydrochloride
    0591-2788tizanidine hydrochloridetizanidine hydrochloride
    0591-2789tizanidine hydrochloridetizanidine hydrochloride
    0591-2790tizanidine hydrochloridetizanidine hydrochloride
    21695-126TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    21695-127TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    35356-662TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    42291-810Tizanidine HydrochlorideTizanidine Hydrochloride
    42291-811Tizanidine HydrochlorideTizanidine Hydrochloride
    42291-812Tizanidine HydrochlorideTizanidine Hydrochloride
    45865-954Tizanidine HydrochlorideTizanidine Hydrochloride
    46708-491Tizanidine HydrochlorideTizanidine Hydrochloride
    46708-492Tizanidine HydrochlorideTizanidine Hydrochloride
    46708-493Tizanidine HydrochlorideTizanidine Hydrochloride
    49884-611tizanidine hydrochloridetizanidine hydrochloride
    49884-719tizanidine hydrochloridetizanidine hydrochloride
    49884-765tizanidine hydrochloridetizanidine hydrochloride
    49999-347Tizanidine HydrochlorideTizanidine Hydrochloride

    Trademark Results [Zanaflex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZANAFLEX
    ZANAFLEX
    75186534 2383531 Live/Registered
    COVIS PHARMA B.V.
    1996-10-15
    ZANAFLEX
    ZANAFLEX
    74400930 1906277 Dead/Cancelled
    ELAN PHARMACEUTICALS, INC.
    1993-06-09
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