zanaflex

Generic: tizanidine hydrochloride

Labeler: legacy pharma usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zanaflex
Generic Name tizanidine hydrochloride
Labeler legacy pharma usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 6 mg/1

Manufacturer
Legacy Pharma USA, Inc.

Identifiers & Regulatory

Product NDC 83107-003
Product ID 83107-003_476ae6e6-0732-af36-e063-6394a90a7c02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021447
Listing Expiration 2027-12-31
Marketing Start 2018-08-01

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 83107003
Hyphenated Format 83107-003

Supplemental Identifiers

RxCUI
153735 313413 485484 485485 485486 580267 583165 583211
UPC
0383107004158
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 zanaflex (source: ndc)
Generic Name tizanidine hydrochloride (source: ndc)
Application Number NDA021447 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 150 CAPSULE in 1 BOTTLE (83107-003-15)
source: ndc

Packages (1)

83107-003-15 150 CAPSULE in 1 BOTTLE (83107-003-15)

Ingredients (1)

tizanidine hydrochloride (6 mg/1)

Linked Drug Pages (1)

Zanaflex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "476ae6e6-0732-af36-e063-6394a90a7c02", "openfda": {"upc": ["0383107004158"], "unii": ["B53E3NMY5C"], "rxcui": ["153735", "313413", "485484", "485485", "485486", "580267", "583165", "583211"], "spl_set_id": ["60c27d35-7349-4fc6-86ad-70fffdbe3e08"], "manufacturer_name": ["Legacy Pharma USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 CAPSULE in 1 BOTTLE (83107-003-15)", "package_ndc": "83107-003-15", "marketing_start_date": "20180801"}], "brand_name": "Zanaflex", "product_id": "83107-003_476ae6e6-0732-af36-e063-6394a90a7c02", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "83107-003", "generic_name": "tizanidine hydrochloride", "labeler_name": "Legacy Pharma USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zanaflex", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "NDA021447", "marketing_category": "NDA", "marketing_start_date": "20180801", "listing_expiration_date": "20271231"}