tizanidine

Generic: tizanidine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler direct_rx
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 6 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-526
Product ID 72189-526_3cbc5365-9206-61c0-e063-6294a90aa3b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210267
Listing Expiration 2026-12-31
Marketing Start 2023-12-06

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 72189526
Hyphenated Format 72189-526

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 (source: ndc)
Generic Name tizanidine (source: ndc)
Application Number ANDA210267 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (72189-526-30)
  • 60 CAPSULE in 1 BOTTLE (72189-526-60)
source: ndc

Packages (2)

72189-526-30 30 CAPSULE in 1 BOTTLE (72189-526-30) 72189-526-60 60 CAPSULE in 1 BOTTLE (72189-526-60)

Ingredients (1)

tizanidine hydrochloride (6 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": "3cbc5365-9206-61c0-e063-6294a90aa3b7", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484"], "spl_set_id": ["0bdc188d-b895-acbc-e063-6294a90acd68"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72189-526-30)", "package_ndc": "72189-526-30", "marketing_start_date": "20231206"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (72189-526-60)", "package_ndc": "72189-526-60", "marketing_start_date": "20231206"}], "brand_name": "Tizanidine", "product_id": "72189-526_3cbc5365-9206-61c0-e063-6294a90aa3b7", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72189-526", "generic_name": "Tizanidine", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA210267", "marketing_category": "ANDA", "marketing_start_date": "20231206", "listing_expiration_date": "20261231"}