tizanidine

Generic: tizanidine

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

Drug Facts

Product Profile

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

tizanidine hydrochloride 4 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8802
Product ID 68788-8802_6e97c1ba-8171-4707-98ee-61afed75daac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091283
Listing Expiration 2026-12-31
Marketing Start 2025-01-02

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 687888802
Hyphenated Format 68788-8802

Supplemental Identifiers

RxCUI
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 ANDA091283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8802-1)
  • 20 TABLET in 1 BOTTLE (68788-8802-2)
  • 30 TABLET in 1 BOTTLE (68788-8802-3)
  • 60 TABLET in 1 BOTTLE (68788-8802-6)
  • 120 TABLET in 1 BOTTLE (68788-8802-8)
  • 90 TABLET in 1 BOTTLE (68788-8802-9)
source: ndc

Packages (6)

68788-8802-1 100 TABLET in 1 BOTTLE (68788-8802-1) 68788-8802-2 20 TABLET in 1 BOTTLE (68788-8802-2) 68788-8802-3 30 TABLET in 1 BOTTLE (68788-8802-3) 68788-8802-6 60 TABLET in 1 BOTTLE (68788-8802-6) 68788-8802-8 120 TABLET in 1 BOTTLE (68788-8802-8) 68788-8802-9 90 TABLET in 1 BOTTLE (68788-8802-9)

Ingredients (1)

tizanidine hydrochloride (4 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": "6e97c1ba-8171-4707-98ee-61afed75daac", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["6e97c1ba-8171-4707-98ee-61afed75daac"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8802-1)", "package_ndc": "68788-8802-1", "marketing_start_date": "20250102"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-8802-2)", "package_ndc": "68788-8802-2", "marketing_start_date": "20250102"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8802-3)", "package_ndc": "68788-8802-3", "marketing_start_date": "20250102"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8802-6)", "package_ndc": "68788-8802-6", "marketing_start_date": "20250102"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68788-8802-8)", "package_ndc": "68788-8802-8", "marketing_start_date": "20250102"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8802-9)", "package_ndc": "68788-8802-9", "marketing_start_date": "20250102"}], "brand_name": "Tizanidine", "product_id": "68788-8802_6e97c1ba-8171-4707-98ee-61afed75daac", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "68788-8802", "generic_name": "Tizanidine", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA091283", "marketing_category": "ANDA", "marketing_start_date": "20250102", "listing_expiration_date": "20261231"}