tizanidine

Generic: tizanidine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1016
Product ID 71335-1016_f623a735-841a-4e73-ae38-e4d5d27a055f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076416
Listing Expiration 2026-12-31
Marketing Start 2003-12-11

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 713351016
Hyphenated Format 71335-1016

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 ANDA076416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 112 TABLET in 1 BOTTLE (71335-1016-0)
  • 30 TABLET in 1 BOTTLE (71335-1016-1)
  • 60 TABLET in 1 BOTTLE (71335-1016-2)
  • 90 TABLET in 1 BOTTLE (71335-1016-3)
  • 120 TABLET in 1 BOTTLE (71335-1016-4)
  • 20 TABLET in 1 BOTTLE (71335-1016-5)
  • 45 TABLET in 1 BOTTLE (71335-1016-6)
  • 140 TABLET in 1 BOTTLE (71335-1016-7)
  • 84 TABLET in 1 BOTTLE (71335-1016-8)
  • 28 TABLET in 1 BOTTLE (71335-1016-9)
source: ndc

Packages (10)

71335-1016-0 112 TABLET in 1 BOTTLE (71335-1016-0) 71335-1016-1 30 TABLET in 1 BOTTLE (71335-1016-1) 71335-1016-2 60 TABLET in 1 BOTTLE (71335-1016-2) 71335-1016-3 90 TABLET in 1 BOTTLE (71335-1016-3) 71335-1016-4 120 TABLET in 1 BOTTLE (71335-1016-4) 71335-1016-5 20 TABLET in 1 BOTTLE (71335-1016-5) 71335-1016-6 45 TABLET in 1 BOTTLE (71335-1016-6) 71335-1016-7 140 TABLET in 1 BOTTLE (71335-1016-7) 71335-1016-8 84 TABLET in 1 BOTTLE (71335-1016-8) 71335-1016-9 28 TABLET in 1 BOTTLE (71335-1016-9)

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": "f623a735-841a-4e73-ae38-e4d5d27a055f", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["03fa03a6-fd05-4f17-872a-3c123330935d"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "112 TABLET in 1 BOTTLE (71335-1016-0)", "package_ndc": "71335-1016-0", "marketing_start_date": "20220202"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1016-1)", "package_ndc": "71335-1016-1", "marketing_start_date": "20190311"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1016-2)", "package_ndc": "71335-1016-2", "marketing_start_date": "20190115"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1016-3)", "package_ndc": "71335-1016-3", "marketing_start_date": "20190117"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71335-1016-4)", "package_ndc": "71335-1016-4", "marketing_start_date": "20190305"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71335-1016-5)", "package_ndc": "71335-1016-5", "marketing_start_date": "20190219"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71335-1016-6)", "package_ndc": "71335-1016-6", "marketing_start_date": "20190621"}, {"sample": false, "description": "140 TABLET in 1 BOTTLE (71335-1016-7)", "package_ndc": "71335-1016-7", "marketing_start_date": "20220202"}, {"sample": false, "description": "84 TABLET in 1 BOTTLE (71335-1016-8)", "package_ndc": "71335-1016-8", "marketing_start_date": "20220202"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71335-1016-9)", "package_ndc": "71335-1016-9", "marketing_start_date": "20220202"}], "brand_name": "Tizanidine", "product_id": "71335-1016_f623a735-841a-4e73-ae38-e4d5d27a055f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "71335-1016", "generic_name": "Tizanidine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076416", "marketing_category": "ANDA", "marketing_start_date": "20031211", "listing_expiration_date": "20261231"}