tizanidine

Generic: tizanidine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-455
Product ID 43063-455_47d2acba-fb93-f1a3-e063-6394a90aa13f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076286
Listing Expiration 2027-12-31
Marketing Start 2002-07-03

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 43063455
Hyphenated Format 43063-455

Supplemental Identifiers

RxCUI
313413
UPC
0343063455906
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 ANDA076286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE, PLASTIC (43063-455-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (43063-455-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-455-30)
  • 40 TABLET in 1 BOTTLE, PLASTIC (43063-455-40)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-455-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-455-90)
source: ndc

Packages (6)

43063-455-15 15 TABLET in 1 BOTTLE, PLASTIC (43063-455-15) 43063-455-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-455-20) 43063-455-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-455-30) 43063-455-40 40 TABLET in 1 BOTTLE, PLASTIC (43063-455-40) 43063-455-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-455-60) 43063-455-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-455-90)

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": "47d2acba-fb93-f1a3-e063-6394a90aa13f", "openfda": {"upc": ["0343063455906"], "unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["ac897a5a-677b-4a6e-abb1-b810470200fc"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (43063-455-15)", "package_ndc": "43063-455-15", "marketing_start_date": "20161122"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (43063-455-20)", "package_ndc": "43063-455-20", "marketing_start_date": "20161122"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-455-30)", "package_ndc": "43063-455-30", "marketing_start_date": "20161122"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE, PLASTIC (43063-455-40)", "package_ndc": "43063-455-40", "marketing_start_date": "20200601"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-455-60)", "package_ndc": "43063-455-60", "marketing_start_date": "20200601"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-455-90)", "package_ndc": "43063-455-90", "marketing_start_date": "20200601"}], "brand_name": "Tizanidine", "product_id": "43063-455_47d2acba-fb93-f1a3-e063-6394a90aa13f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "43063-455", "generic_name": "Tizanidine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076286", "marketing_category": "ANDA", "marketing_start_date": "20020703", "listing_expiration_date": "20271231"}