tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine hydrochloride
Generic Name tizanidine hydrochloride
Labeler apotex corp.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 6 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-2650
Product ID 60505-2650_f68c762c-26fc-7c61-1a94-6b5110937eea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078868
Listing Expiration 2026-12-31
Marketing Start 2012-02-06

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 605052650
Hyphenated Format 60505-2650

Supplemental Identifiers

RxCUI
485484 485485 485486
UPC
0360505265077 0360505264971 0360505264872
UNII
B53E3NMY5C

Packaging Origin

Original Packager
true

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 ANDA078868 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-3)
  • 150 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-7)
  • 1000 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-8)
source: ndc

Packages (3)

60505-2650-3 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-3) 60505-2650-7 150 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-7) 60505-2650-8 1000 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-8)

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": "f68c762c-26fc-7c61-1a94-6b5110937eea", "openfda": {"upc": ["0360505265077", "0360505264971", "0360505264872"], "unii": ["B53E3NMY5C"], "rxcui": ["485484", "485485", "485486"], "spl_set_id": ["3dd09a0d-a782-1d6d-a552-b71e5bcbf2fe"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-3)", "package_ndc": "60505-2650-3", "marketing_start_date": "20120206"}, {"sample": false, "description": "150 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-7)", "package_ndc": "60505-2650-7", "marketing_start_date": "20120206"}, {"sample": false, "description": "1000 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2650-8)", "package_ndc": "60505-2650-8", "marketing_start_date": "20120206"}], "brand_name": "Tizanidine Hydrochloride", "product_id": "60505-2650_f68c762c-26fc-7c61-1a94-6b5110937eea", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "60505-2650", "generic_name": "Tizanidine Hydrochloride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine Hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA078868", "marketing_category": "ANDA", "marketing_start_date": "20120206", "listing_expiration_date": "20261231"}