NDC 68387-140

TIZANIDINE HYDROCHLORIDE

Tizanidine Hydrochloride

TIZANIDINE HYDROCHLORIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Keltman Pharmaceuticals Inc.. The primary component is Tizanidine Hydrochloride.

Product ID68387-140_8eba76b2-3510-40b2-a169-e8c1aea145e1
NDC68387-140
Product TypeHuman Prescription Drug
Proprietary NameTIZANIDINE HYDROCHLORIDE
Generic NameTizanidine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA076347
Labeler NameKeltman Pharmaceuticals Inc.
Substance NameTIZANIDINE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68387-140-10

10 TABLET in 1 BOTTLE, PLASTIC (68387-140-10)
Marketing Start Date2005-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-140-90 [68387014090]

TIZANIDINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076347
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-06-01
Inactivation Date2019-10-21

NDC 68387-140-60 [68387014060]

TIZANIDINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076347
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-06-01
Inactivation Date2019-10-21

NDC 68387-140-30 [68387014030]

TIZANIDINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076347
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-12
Inactivation Date2019-10-21

NDC 68387-140-10 [68387014010]

TIZANIDINE HYDROCHLORIDE TABLET
Marketing CategoryANDA
Application NumberANDA076347
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-07-12
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:0df212f5-f77b-4d94-8fd0-0b40d0e9a1c8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313412
  • 313413

    • Pharmacological Class

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

    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
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