NDC 67877-612

Tizanidne hydrochloride

Tizanidne Hydrochloride

Tizanidne hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Tizanidine Hydrochloride.

Product ID67877-612_06274de3-1c99-412b-b62a-cd3a0caa2db4
NDC67877-612
Product TypeHuman Prescription Drug
Proprietary NameTizanidne hydrochloride
Generic NameTizanidne Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-03-29
Marketing CategoryANDA / ANDA
Application NumberANDA212196
Labeler NameAscend Laboratories, LLC
Substance NameTIZANIDINE HYDROCHLORIDE
Active Ingredient Strength6 mg/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 67877-612-05

500 CAPSULE in 1 BOTTLE (67877-612-05)
Marketing Start Date2019-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67877-612-05 [67877061205]

Tizanidne hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA212196
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-29

NDC 67877-612-15 [67877061215]

Tizanidne hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA212196
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-29

NDC 67877-612-33 [67877061233]

Tizanidne hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA212196
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-29

Drug Details

Active Ingredients

IngredientStrength
TIZANIDINE HYDROCHLORIDE6 mg/1

OpenFDA Data

SPL SET ID:d7c97b79-da59-4e86-a01b-f91046d04f74
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485485
  • 485484
  • 485486
  • UPC Code
  • 0367877610337
  • 0367877610153
  • 0367877611334
  • 0367877612331
  • 0367877612157
  • 0367877611150
  • 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 "Tizanidne hydrochloride" or generic name "Tizanidne Hydrochloride"

    NDCBrand NameGeneric Name
    63629-8871Tizanidne hydrochlorideTizanidne Hydrochloride
    63629-8872Tizanidne hydrochlorideTizanidne Hydrochloride
    63629-8873Tizanidne hydrochlorideTizanidne Hydrochloride
    67296-1793Tizanidne hydrochlorideTizanidne Hydrochloride
    67877-610Tizanidne hydrochlorideTizanidne Hydrochloride
    67877-611Tizanidne hydrochlorideTizanidne Hydrochloride
    67877-612Tizanidne hydrochlorideTizanidne Hydrochloride
    68788-7962Tizanidne hydrochlorideTizanidne Hydrochloride
    71335-2077Tizanidne hydrochlorideTizanidne Hydrochloride
    76420-231Tizanidne hydrochlorideTizanidne Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.