NDC 0378-0724

Tizanidine

Tizanidine

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

Product ID0378-0724_aa034a4c-1b31-4f09-b505-717da8fd3558
NDC0378-0724
Product TypeHuman Prescription Drug
Proprietary NameTizanidine
Generic NameTizanidine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-05-06
Marketing CategoryANDA / ANDA
Application NumberANDA076354
Labeler NameMylan 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 Through2020-12-31

Packaging

NDC 0378-0724-19

150 TABLET in 1 BOTTLE, PLASTIC (0378-0724-19)
Marketing Start Date2003-05-06
Marketing End Date2021-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0724-01 [00378072401]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076354
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-05-06
Marketing End Date2017-12-04

NDC 0378-0724-05 [00378072405]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076354
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-05-06
Marketing End Date2017-12-04

NDC 0378-0724-19 [00378072419]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076354
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-05-06
Marketing End Date2021-02-28

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:b4227d39-6f9e-5ded-4169-087ce91a75b5
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" or generic name "Tizanidine"

    NDCBrand NameGeneric Name
    0378-0722Tizanidinetizanidine
    0378-0724Tizanidinetizanidine
    0615-5574TizanidineTizanidine
    0615-6564TizanidineTizanidine
    0615-7996TizanidineTizanidine
    0615-8274TizanidineTizanidine
    0615-8360TizanidineTizanidine
    0904-6418tizanidinetizanidine
    0904-6898TizanidineTizanidine
    10544-576tizanidinetizanidine
    10544-587tizanidinetizanidine
    10544-863tizanidinetizanidine
    10544-890TizanidineTizanidine
    16714-171TizanidineTizanidine
    16714-172TizanidineTizanidine
    29300-168TizanidineTizanidine
    29300-169TizanidineTizanidine
    33261-103TizanidineTizanidine
    33261-104TizanidineTizanidine
    35356-662TizanidineTizanidine
    42291-808TizanidineTizanidine
    42291-809TizanidineTizanidine
    43063-455TizanidineTizanidine
    43063-868TizanidineTizanidine
    67877-614TizanidineTizanidine
    67877-613TizanidineTizanidine
    68071-3288tizanidinetizanidine
    68071-4463TizanidineTizanidine
    68084-645TizanidineTizanidine
    68084-775TizanidineTizanidine
    68788-6365TizanidineTizanidine
    68788-6444TizanidineTizanidine
    68788-9514tizanidinetizanidine
    68788-9091TizanidineTizanidine
    68788-9092TizanidineTizanidine
    68788-9497tizanidinetizanidine
    69420-1506TizanidineTizanidine
    69420-1504TizanidineTizanidine
    69420-1502TizanidineTizanidine
    70518-0133TizanidineTizanidine
    70518-0774tizanidinetizanidine
    70518-0573TizanidineTizanidine
    70518-1598TizanidineTizanidine
    70518-1439TizanidineTizanidine
    70710-1104tizanidinetizanidine
    70771-1336tizanidinetizanidine
    70710-1105tizanidinetizanidine
    70771-1335tizanidinetizanidine
    71335-0424TizanidineTizanidine
    71335-0914TizanidineTizanidine
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