tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tizanidine hydrochloride 4 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-811
Product ID 42291-811_423ead2f-fbbc-830d-e063-6294a90aacfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078868
Listing Expiration 2026-12-31
Marketing Start 2014-06-20

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 42291811
Hyphenated Format 42291-811

Supplemental Identifiers

RxCUI
485484 485485 485486
UPC
0342291810150 0342291812154 0342291811157
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 hydrochloride (source: ndc)
Generic Name tizanidine hydrochloride (source: ndc)
Application Number ANDA078868 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15)
source: ndc

Packages (1)

42291-811-15 150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15)

Ingredients (1)

tizanidine hydrochloride (4 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": "423ead2f-fbbc-830d-e063-6294a90aacfe", "openfda": {"upc": ["0342291810150", "0342291812154", "0342291811157"], "unii": ["B53E3NMY5C"], "rxcui": ["485484", "485485", "485486"], "spl_set_id": ["acc8f9f6-ceb6-0505-8f11-fd7e1f105af3"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15)", "package_ndc": "42291-811-15", "marketing_start_date": "20140620"}], "brand_name": "Tizanidine Hydrochloride", "product_id": "42291-811_423ead2f-fbbc-830d-e063-6294a90aacfe", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "42291-811", "generic_name": "Tizanidine Hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine Hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA078868", "marketing_category": "ANDA", "marketing_start_date": "20140620", "listing_expiration_date": "20261231"}