tizanidine

Generic: tizanidine

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler viona pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-096
Product ID 72578-096_8fd84300-3ed6-42ff-b20c-608ea5dc96eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208187
Listing Expiration 2026-12-31
Marketing Start 2021-03-04

Pharmacologic Class

Classes
adrenergic alpha2-agonists [moa] central alpha-2 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578096
Hyphenated Format 72578-096

Supplemental Identifiers

RxCUI
313412 313413
UNII
B53E3NMY5C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tizanidine (source: ndc)
Generic Name tizanidine (source: ndc)
Application Number ANDA208187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72578-096-06)
  • 1000 TABLET in 1 BOTTLE (72578-096-10)
  • 150 TABLET in 1 BOTTLE (72578-096-21)
  • 10 BLISTER PACK in 1 CARTON (72578-096-77) / 10 TABLET in 1 BLISTER PACK (72578-096-30)
source: ndc

Packages (4)

72578-096-06 30 TABLET in 1 BOTTLE (72578-096-06) 72578-096-10 1000 TABLET in 1 BOTTLE (72578-096-10) 72578-096-21 150 TABLET in 1 BOTTLE (72578-096-21) 72578-096-77 10 BLISTER PACK in 1 CARTON (72578-096-77) / 10 TABLET in 1 BLISTER PACK (72578-096-30)

Ingredients (1)

tizanidine hydrochloride (2 mg/1)

Linked Drug Pages (1)

tizanidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8fd84300-3ed6-42ff-b20c-608ea5dc96eb", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["8ac00d59-bb80-4530-afe7-90e04a2130b2"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72578-096-06)", "package_ndc": "72578-096-06", "marketing_start_date": "20210304"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (72578-096-10)", "package_ndc": "72578-096-10", "marketing_start_date": "20210304"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (72578-096-21)", "package_ndc": "72578-096-21", "marketing_start_date": "20210304"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72578-096-77)  / 10 TABLET in 1 BLISTER PACK (72578-096-30)", "package_ndc": "72578-096-77", "marketing_start_date": "20210304"}], "brand_name": "tizanidine", "product_id": "72578-096_8fd84300-3ed6-42ff-b20c-608ea5dc96eb", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72578-096", "generic_name": "tizanidine", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA208187", "marketing_category": "ANDA", "marketing_start_date": "20210304", "listing_expiration_date": "20261231"}