NDC 71335-0914

Tizanidine

Tizanidine

Tizanidine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Tizanidine Hydrochloride.

Product ID71335-0914_b345b67f-16c3-4ee0-9da3-3d9869a08f91
NDC71335-0914
Product TypeHuman Prescription Drug
Proprietary NameTizanidine
Generic NameTizanidine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA091283
Labeler NameBryant Ranch Prepack
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 71335-0914-0

112 TABLET in 1 BOTTLE (71335-0914-0)
Marketing Start Date2014-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0914-4 [71335091404]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 71335-0914-7 [71335091407]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-28

NDC 71335-0914-9 [71335091409]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 71335-0914-1 [71335091401]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 71335-0914-8 [71335091408]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 71335-0914-3 [71335091403]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 71335-0914-0 [71335091400]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 71335-0914-6 [71335091406]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 71335-0914-5 [71335091405]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

NDC 71335-0914-2 [71335091402]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-28

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:f87e30ce-a60a-41e3-b5d6-7e2966143961
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.