NDC 71335-1016

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 ID71335-1016_03fa03a6-fd05-4f17-872a-3c123330935d
NDC71335-1016
Product TypeHuman Prescription Drug
Proprietary NameTizanidine
Generic NameTizanidine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA076416
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 Through2023-12-31

Packaging

NDC 71335-1016-0

112 TABLET in 1 BOTTLE (71335-1016-0)
Marketing Start Date2022-02-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1016-3 [71335101603]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-23

NDC 71335-1016-1 [71335101601]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-23

NDC 71335-1016-7 [71335101607]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-23

NDC 71335-1016-5 [71335101605]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-23

NDC 71335-1016-8 [71335101608]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-23

NDC 71335-1016-9 [71335101609]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-23

NDC 71335-1016-4 [71335101604]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-23

NDC 71335-1016-2 [71335101602]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-10-23

NDC 71335-1016-6 [71335101606]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-23

NDC 71335-1016-0 [71335101600]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-10-23

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:03fa03a6-fd05-4f17-872a-3c123330935d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313413
  • Pharmacological Class

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