tizanidne hydrochloride

Generic: tizanidne hydrochloride

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

Drug Facts

Product Profile

Brand Name tizanidne hydrochloride
Generic Name tizanidne hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8798
Product ID 68788-8798_ff9d2f6a-8654-4dbe-ab07-4f9cacda54ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212196
Listing Expiration 2027-12-31
Marketing Start 2025-01-01

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 687888798
Hyphenated Format 68788-8798

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 tizanidne hydrochloride (source: ndc)
Generic Name tizanidne hydrochloride (source: ndc)
Application Number ANDA212196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68788-8798-1)
  • 20 CAPSULE in 1 BOTTLE (68788-8798-2)
  • 30 CAPSULE in 1 BOTTLE (68788-8798-3)
  • 60 CAPSULE in 1 BOTTLE (68788-8798-6)
  • 120 CAPSULE in 1 BOTTLE (68788-8798-8)
  • 90 CAPSULE in 1 BOTTLE (68788-8798-9)
source: ndc

Packages (6)

68788-8798-1 100 CAPSULE in 1 BOTTLE (68788-8798-1) 68788-8798-2 20 CAPSULE in 1 BOTTLE (68788-8798-2) 68788-8798-3 30 CAPSULE in 1 BOTTLE (68788-8798-3) 68788-8798-6 60 CAPSULE in 1 BOTTLE (68788-8798-6) 68788-8798-8 120 CAPSULE in 1 BOTTLE (68788-8798-8) 68788-8798-9 90 CAPSULE in 1 BOTTLE (68788-8798-9)

Ingredients (1)

tizanidine hydrochloride (4 mg/1)

Linked Drug Pages (1)

Tizanidne hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff9d2f6a-8654-4dbe-ab07-4f9cacda54ae", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485485"], "spl_set_id": ["3f569c5a-ec9d-4356-ac04-c17714ff68d1"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68788-8798-1)", "package_ndc": "68788-8798-1", "marketing_start_date": "20250101"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (68788-8798-2)", "package_ndc": "68788-8798-2", "marketing_start_date": "20250101"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8798-3)", "package_ndc": "68788-8798-3", "marketing_start_date": "20250101"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8798-6)", "package_ndc": "68788-8798-6", "marketing_start_date": "20250101"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (68788-8798-8)", "package_ndc": "68788-8798-8", "marketing_start_date": "20250101"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68788-8798-9)", "package_ndc": "68788-8798-9", "marketing_start_date": "20250101"}], "brand_name": "Tizanidne hydrochloride", "product_id": "68788-8798_ff9d2f6a-8654-4dbe-ab07-4f9cacda54ae", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "68788-8798", "generic_name": "Tizanidne Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidne hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA212196", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20271231"}