NDC 63187-009

Tizanidine

Tizanidine

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

Product ID63187-009_3a87d28a-6a46-4281-b82d-c82147a07fa3
NDC63187-009
Product TypeHuman Prescription Drug
Proprietary NameTizanidine
Generic NameTizanidine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2002-07-03
Marketing CategoryANDA / ANDA
Application NumberANDA076286
Labeler NameProficient Rx LP
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 63187-009-30

30 TABLET in 1 BOTTLE (63187-009-30)
Marketing Start Date2014-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-009-30 [63187000930]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076286
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-01
Inactivation Date2019-11-27
Reactivation Date2019-12-06

NDC 63187-009-60 [63187000960]

Tizanidine TABLET
Marketing CategoryANDA
Application NumberANDA076286
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-01
Inactivation Date2019-11-27
Reactivation Date2019-12-06

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:c2353d09-3cb4-486e-8ae7-29339c1ba76b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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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