NDC 60505-2649

Tizanidine Hydrochloride

Tizanidine Hydrochloride

Tizanidine Hydrochloride is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Tizanidine Hydrochloride.

Product ID60505-2649_80e7808e-6d8e-8b2d-6955-0afb3b420000
NDC60505-2649
Product TypeHuman Prescription Drug
Proprietary NameTizanidine Hydrochloride
Generic NameTizanidine Hydrochloride
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2012-02-06
Marketing CategoryANDA / ANDA
Application NumberANDA078868
Labeler NameApotex Corp.
Substance NameTIZANIDINE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60505-2649-3

30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2649-3)
Marketing Start Date2012-02-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-2649-3 [60505264903]

Tizanidine Hydrochloride CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA078868
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-06

NDC 60505-2649-7 [60505264907]

Tizanidine Hydrochloride CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA078868
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-02-06

NDC 60505-2649-0 [60505264900]

Tizanidine Hydrochloride CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA078868
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-06
Marketing End Date2013-11-17

NDC 60505-2649-8 [60505264908]

Tizanidine Hydrochloride CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA078868
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-06

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485485
  • 485484
  • 485486

    • Pharmacological Class

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

    Medicade Reported Pricing

    60505264907 TIZANIDINE HCL 4 MG CAPSULE

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    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
    68387-130TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    68387-140TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    68788-6431tizanidine hydrochloridetizanidine hydrochloride
    70710-1112tizanidine hydrochloridetizanidine hydrochloride
    70771-1067tizanidine hydrochloridetizanidine hydrochloride
    70771-1069tizanidine hydrochloridetizanidine hydrochloride
    70710-1113tizanidine hydrochloridetizanidine hydrochloride
    70710-1111tizanidine hydrochloridetizanidine hydrochloride
    70771-1068tizanidine hydrochloridetizanidine hydrochloride
    71335-0317Tizanidine HydrochlorideTizanidine Hydrochloride
    71610-114tizanidine hydrochloridetizanidine hydrochloride
    50742-224TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    50742-226TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    50742-225TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    55289-784tizanidine hydrochloridetizanidine hydrochloride
    55700-259tizanidine hydrochloridetizanidine hydrochloride
    59746-670Tizanidine HydrochlorideTizanidine Hydrochloride
    59746-672Tizanidine HydrochlorideTizanidine Hydrochloride
    59746-671Tizanidine HydrochlorideTizanidine Hydrochloride
    60505-2649Tizanidine HydrochlorideTizanidine Hydrochloride
    60505-2650Tizanidine HydrochlorideTizanidine Hydrochloride
    60505-2648Tizanidine HydrochlorideTizanidine Hydrochloride
    61919-196TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE
    63629-5139tizanidine hydrochloridetizanidine hydrochloride
    63629-6537tizanidine hydrochloridetizanidine hydrochloride
    71209-065Tizanidine hydrochlorideTizanidine hydrochloride
    71209-066Tizanidine hydrochlorideTizanidine hydrochloride
    71209-064Tizanidine hydrochlorideTizanidine hydrochloride
    55700-789Tizanidine HydrochlorideTizanidine Hydrochloride
    10144-594Zanaflextizanidine hydrochloride
    10144-602Zanaflextizanidine hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.