NDC 61919-811

TIZANDINE

Tizandine

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

Product ID61919-811_87d9280d-684f-f5f5-e053-2a95a90aefdf
NDC61919-811
Product TypeHuman Prescription Drug
Proprietary NameTIZANDINE
Generic NameTizandine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA091283
Labeler NameDirectRX
Substance NameTIZANIDINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-811-60

60 TABLET in 1 BOTTLE (61919-811-60)
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-811-30 [61919081130]

TIZANDINE TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-08

NDC 61919-811-72 [61919081172]

TIZANDINE TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-19

NDC 61919-811-60 [61919081160]

TIZANDINE TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-01

NDC 61919-811-15 [61919081115]

TIZANDINE TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-30

NDC 61919-811-90 [61919081190]

TIZANDINE TABLET
Marketing CategoryANDA
Application NumberANDA091283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-13

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Pharmacological Class

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

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