tizanidine hydrochloride

Generic: tizanidine hydrochloride

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

Drug Facts

Product Profile

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

tizanidine hydrochloride 4 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0474
Product ID 80425-0474_43cfd33c-ce85-2381-e063-6394a90a4f1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213798
Listing Expiration 2026-12-31
Marketing Start 2025-01-20

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 804250474
Hyphenated Format 80425-0474

Supplemental Identifiers

RxCUI
485485
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 hydrochloride (source: ndc)
Generic Name tizanidine hydrochloride (source: ndc)
Application Number ANDA213798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (80425-0474-1)
  • 60 CAPSULE in 1 BOTTLE (80425-0474-2)
  • 90 CAPSULE in 1 BOTTLE (80425-0474-3)
  • 120 CAPSULE in 1 BOTTLE (80425-0474-4)
source: ndc

Packages (4)

80425-0474-1 30 CAPSULE in 1 BOTTLE (80425-0474-1) 80425-0474-2 60 CAPSULE in 1 BOTTLE (80425-0474-2) 80425-0474-3 90 CAPSULE in 1 BOTTLE (80425-0474-3) 80425-0474-4 120 CAPSULE in 1 BOTTLE (80425-0474-4)

Ingredients (1)

tizanidine hydrochloride (4 mg/1)

Linked Drug Pages (1)

tizanidine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43cfd33c-ce85-2381-e063-6394a90a4f1a", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485485"], "spl_set_id": ["2c2bdad9-74a5-8508-e063-6294a90aac7f"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0474-1)", "package_ndc": "80425-0474-1", "marketing_start_date": "20250120"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (80425-0474-2)", "package_ndc": "80425-0474-2", "marketing_start_date": "20250120"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (80425-0474-3)", "package_ndc": "80425-0474-3", "marketing_start_date": "20250120"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (80425-0474-4)", "package_ndc": "80425-0474-4", "marketing_start_date": "20251117"}], "brand_name": "tizanidine hydrochloride", "product_id": "80425-0474_43cfd33c-ce85-2381-e063-6394a90a4f1a", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "80425-0474", "generic_name": "tizanidine hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA213798", "marketing_category": "ANDA", "marketing_start_date": "20250120", "listing_expiration_date": "20261231"}