NDC 61919-221

TIZANIDINE

Tizanidine

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

Product ID61919-221_90041ce8-f818-f6e6-e053-2995a90a5c3f
NDC61919-221
Product TypeHuman Prescription Drug
Proprietary NameTIZANIDINE
Generic NameTizanidine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-08-13
Marketing CategoryANDA / ANDA
Application NumberANDA076533
Labeler NameDirect_Rx
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 61919-221-86

270 TABLET in 1 BOTTLE (61919-221-86)
Marketing Start Date2019-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-221-30 [61919022130]

TIZANIDINE TABLET
Marketing CategoryANDA
Application NumberANDA076533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-221-72 [61919022172]

TIZANIDINE TABLET
Marketing CategoryANDA
Application NumberANDA076533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01
Inactivation Date2020-01-31

NDC 61919-221-86 [61919022186]

TIZANIDINE TABLET
Marketing CategoryANDA
Application NumberANDA076533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-13

NDC 61919-221-90 [61919022190]

TIZANIDINE TABLET
Marketing CategoryANDA
Application NumberANDA076533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-221-15 [61919022115]

TIZANIDINE TABLET
Marketing CategoryANDA
Application NumberANDA076533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-30

NDC 61919-221-60 [61919022160]

TIZANIDINE TABLET
Marketing CategoryANDA
Application NumberANDA076533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:54bd58ee-76f6-44e7-83bb-fe752c3cbf9a
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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