tizanidine

Generic: tizanidine

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-169
Product ID 29300-169_06c83876-99c5-4ed1-8727-1a0d93452020
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091283
Listing Expiration 2026-12-31
Marketing Start 2013-04-01

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 29300169
Hyphenated Format 29300-169

Supplemental Identifiers

RxCUI
313412 313413
UPC
0329300168150 0329300169157
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 ANDA091283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 300 TABLET in 1 BOTTLE, PLASTIC (29300-169-03)
  • 500 TABLET in 1 BOTTLE, PLASTIC (29300-169-05)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (29300-169-10)
  • 150 TABLET in 1 BOTTLE, PLASTIC (29300-169-15)
  • 90 TABLET in 1 BOTTLE, PLASTIC (29300-169-19)
source: ndc

Packages (5)

29300-169-03 300 TABLET in 1 BOTTLE, PLASTIC (29300-169-03) 29300-169-05 500 TABLET in 1 BOTTLE, PLASTIC (29300-169-05) 29300-169-10 1000 TABLET in 1 BOTTLE, PLASTIC (29300-169-10) 29300-169-15 150 TABLET in 1 BOTTLE, PLASTIC (29300-169-15) 29300-169-19 90 TABLET in 1 BOTTLE, PLASTIC (29300-169-19)

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": "06c83876-99c5-4ed1-8727-1a0d93452020", "openfda": {"upc": ["0329300168150", "0329300169157"], "unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET in 1 BOTTLE, PLASTIC (29300-169-03)", "package_ndc": "29300-169-03", "marketing_start_date": "20130401"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (29300-169-05)", "package_ndc": "29300-169-05", "marketing_start_date": "20130401"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (29300-169-10)", "package_ndc": "29300-169-10", "marketing_start_date": "20130401"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE, PLASTIC (29300-169-15)", "package_ndc": "29300-169-15", "marketing_start_date": "20130401"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (29300-169-19)", "package_ndc": "29300-169-19", "marketing_start_date": "20230106"}], "brand_name": "Tizanidine", "product_id": "29300-169_06c83876-99c5-4ed1-8727-1a0d93452020", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "29300-169", "generic_name": "Tizanidine", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA091283", "marketing_category": "ANDA", "marketing_start_date": "20130401", "listing_expiration_date": "20261231"}