tizanidine

Generic: tizanidine

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler advanced rx of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0436
Product ID 80425-0436_2aabf642-2907-a735-e063-6394a90a83b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208187
Listing Expiration 2026-12-31
Marketing Start 2024-09-09

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 804250436
Hyphenated Format 80425-0436

Supplemental Identifiers

RxCUI
313412 313413
UNII
B53E3NMY5C

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 (80425-0436-1)
  • 60 TABLET in 1 BOTTLE (80425-0436-2)
  • 90 TABLET in 1 BOTTLE (80425-0436-3)
source: ndc

Packages (3)

80425-0436-1 30 TABLET in 1 BOTTLE (80425-0436-1) 80425-0436-2 60 TABLET in 1 BOTTLE (80425-0436-2) 80425-0436-3 90 TABLET in 1 BOTTLE (80425-0436-3)

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": "2aabf642-2907-a735-e063-6394a90a83b5", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["21b7c8a8-ee07-a204-e063-6394a90a285b"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0436-1)", "package_ndc": "80425-0436-1", "marketing_start_date": "20240909"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (80425-0436-2)", "package_ndc": "80425-0436-2", "marketing_start_date": "20240909"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (80425-0436-3)", "package_ndc": "80425-0436-3", "marketing_start_date": "20240909"}], "brand_name": "Tizanidine", "product_id": "80425-0436_2aabf642-2907-a735-e063-6394a90a83b5", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "80425-0436", "generic_name": "Tizanidine", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20240909", "listing_expiration_date": "20261231"}