tizanidine

Generic: tizanidine

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tizanidine hydrochloride 4 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5268
Product ID 68071-5268_2b622662-d79c-cce4-e063-6294a90a88ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076286
Listing Expiration 2026-12-31
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 680715268
Hyphenated Format 68071-5268

Supplemental Identifiers

RxCUI
313413
UPC
0368071526837
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
  • 30 TABLET in 1 BOTTLE (68071-5268-3)
  • 15 TABLET in 1 BOTTLE (68071-5268-5)
  • 90 TABLET in 1 BOTTLE (68071-5268-9)
source: ndc

Packages (3)

68071-5268-3 30 TABLET in 1 BOTTLE (68071-5268-3) 68071-5268-5 15 TABLET in 1 BOTTLE (68071-5268-5) 68071-5268-9 90 TABLET in 1 BOTTLE (68071-5268-9)

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": "2b622662-d79c-cce4-e063-6294a90a88ff", "openfda": {"upc": ["0368071526837"], "unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["a7470959-8943-215b-e053-2a95a90a7878"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-5268-3)", "package_ndc": "68071-5268-3", "marketing_start_date": "20200604"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (68071-5268-5)", "package_ndc": "68071-5268-5", "marketing_start_date": "20220721"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-5268-9)", "package_ndc": "68071-5268-9", "marketing_start_date": "20220721"}], "brand_name": "Tizanidine", "product_id": "68071-5268_2b622662-d79c-cce4-e063-6294a90a88ff", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "68071-5268", "generic_name": "Tizanidine", "labeler_name": "NuCare 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": "20261231"}