tizanidine

Generic: tizanidine

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

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0251
Product ID 60505-0251_95820c11-e6e2-4f26-6af9-2cc60ef94c41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076533
Listing Expiration 2026-12-31
Marketing Start 2004-01-16

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 605050251
Hyphenated Format 60505-0251

Supplemental Identifiers

RxCUI
313412 313413
UPC
0360505025237
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 (source: ndc)
Generic Name tizanidine (source: ndc)
Application Number ANDA076533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (60505-0251-1)
  • 1000 TABLET in 1 BOTTLE (60505-0251-2)
  • 150 TABLET in 1 BOTTLE (60505-0251-3)
source: ndc

Packages (3)

60505-0251-1 100 TABLET in 1 BOTTLE (60505-0251-1) 60505-0251-2 1000 TABLET in 1 BOTTLE (60505-0251-2) 60505-0251-3 150 TABLET in 1 BOTTLE (60505-0251-3)

Ingredients (1)

tizanidine hydrochloride (2 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": "95820c11-e6e2-4f26-6af9-2cc60ef94c41", "openfda": {"upc": ["0360505025237"], "unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["01c0d3d3-2373-a1b7-822a-80a66291a248"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (60505-0251-1)", "package_ndc": "60505-0251-1", "marketing_start_date": "20040116"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (60505-0251-2)", "package_ndc": "60505-0251-2", "marketing_start_date": "20040116"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (60505-0251-3)", "package_ndc": "60505-0251-3", "marketing_start_date": "20040116"}], "brand_name": "tizanidine", "product_id": "60505-0251_95820c11-e6e2-4f26-6af9-2cc60ef94c41", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "60505-0251", "generic_name": "tizanidine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA076533", "marketing_category": "ANDA", "marketing_start_date": "20040116", "listing_expiration_date": "20261231"}