tizanidine

Generic: tizanidine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1444
Product ID 67046-1444_2d9a2bea-cb13-905f-e063-6294a90a63cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208187
Listing Expiration 2026-12-31
Marketing Start 2021-03-04

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 670461444
Hyphenated Format 67046-1444

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 ANDA208187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1444-3)
source: ndc

Packages (1)

67046-1444-3 30 TABLET in 1 BLISTER PACK (67046-1444-3)

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": "2d9a2bea-cb13-905f-e063-6294a90a63cc", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["2d9a2492-d914-f87b-e063-6394a90a38c6"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1444-3)", "package_ndc": "67046-1444-3", "marketing_start_date": "20250207"}], "brand_name": "tizanidine", "product_id": "67046-1444_2d9a2bea-cb13-905f-e063-6294a90a63cc", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "67046-1444", "generic_name": "tizanidine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA208187", "marketing_category": "ANDA", "marketing_start_date": "20210304", "listing_expiration_date": "20261231"}