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 68788-7781
Product ID 68788-7781_c2ed0d31-f724-4410-85b9-eb03eb7ab9bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076286
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

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 687887781
Hyphenated Format 68788-7781

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 ANDA076286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-7781-1)
  • 20 TABLET in 1 BOTTLE (68788-7781-2)
  • 30 TABLET in 1 BOTTLE (68788-7781-3)
  • 60 TABLET in 1 BOTTLE (68788-7781-6)
  • 120 TABLET in 1 BOTTLE (68788-7781-8)
  • 90 TABLET in 1 BOTTLE (68788-7781-9)
source: ndc

Packages (6)

68788-7781-1 100 TABLET in 1 BOTTLE (68788-7781-1) 68788-7781-2 20 TABLET in 1 BOTTLE (68788-7781-2) 68788-7781-3 30 TABLET in 1 BOTTLE (68788-7781-3) 68788-7781-6 60 TABLET in 1 BOTTLE (68788-7781-6) 68788-7781-8 120 TABLET in 1 BOTTLE (68788-7781-8) 68788-7781-9 90 TABLET in 1 BOTTLE (68788-7781-9)

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": "c2ed0d31-f724-4410-85b9-eb03eb7ab9bc", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["32c3be66-5398-425c-ac65-e57ba819bb43"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-7781-1)", "package_ndc": "68788-7781-1", "marketing_start_date": "20200901"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68788-7781-2)", "package_ndc": "68788-7781-2", "marketing_start_date": "20200901"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-7781-3)", "package_ndc": "68788-7781-3", "marketing_start_date": "20200901"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-7781-6)", "package_ndc": "68788-7781-6", "marketing_start_date": "20200901"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (68788-7781-8)", "package_ndc": "68788-7781-8", "marketing_start_date": "20200901"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-7781-9)", "package_ndc": "68788-7781-9", "marketing_start_date": "20200901"}], "brand_name": "Tizanidine", "product_id": "68788-7781_c2ed0d31-f724-4410-85b9-eb03eb7ab9bc", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "68788-7781", "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": "ANDA076286", "marketing_category": "ANDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}