tizanidine hydrochloride

Generic: tizanidine hydrochloride

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

Drug Facts

Product Profile

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

tizanidine hydrochloride 6 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8478
Product ID 68788-8478_07bad3ac-76c5-4a87-a0e2-e3d5baefee8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210267
Listing Expiration 2026-12-31
Marketing Start 2023-07-06

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 687888478
Hyphenated Format 68788-8478

Supplemental Identifiers

RxCUI
485484
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 ANDA210267 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-1)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-3)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-6)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-9)
source: ndc

Packages (4)

68788-8478-1 100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-1) 68788-8478-3 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-3) 68788-8478-6 60 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-6) 68788-8478-9 90 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-9)

Ingredients (1)

tizanidine hydrochloride (6 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": "07bad3ac-76c5-4a87-a0e2-e3d5baefee8b", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484"], "spl_set_id": ["ae9b6808-632f-4204-8581-bf146dcab69f"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-1)", "package_ndc": "68788-8478-1", "marketing_start_date": "20230706"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-3)", "package_ndc": "68788-8478-3", "marketing_start_date": "20230706"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-6)", "package_ndc": "68788-8478-6", "marketing_start_date": "20230706"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-9)", "package_ndc": "68788-8478-9", "marketing_start_date": "20230706"}], "brand_name": "TIZANIDINE HYDROCHLORIDE", "product_id": "68788-8478_07bad3ac-76c5-4a87-a0e2-e3d5baefee8b", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "68788-8478", "generic_name": "tizanidine hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIZANIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA210267", "marketing_category": "ANDA", "marketing_start_date": "20230706", "listing_expiration_date": "20261231"}