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 68071-3719
Product ID 68071-3719_2bae2620-0abb-7e55-e063-6394a90ad47c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208187
Listing Expiration 2026-12-31
Marketing Start 2021-03-04

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 680713719
Hyphenated Format 68071-3719

Supplemental Identifiers

RxCUI
313413
UPC
0368071371932
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 ANDA208187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68071-3719-3)
  • 90 TABLET in 1 BOTTLE (68071-3719-9)
source: ndc

Packages (2)

68071-3719-3 30 TABLET in 1 BOTTLE (68071-3719-3) 68071-3719-9 90 TABLET in 1 BOTTLE (68071-3719-9)

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": "2bae2620-0abb-7e55-e063-6394a90ad47c", "openfda": {"upc": ["0368071371932"], "unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["26cffb1f-21a0-017f-e063-6394a90afb1a"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-3719-3)", "package_ndc": "68071-3719-3", "marketing_start_date": "20241113"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3719-9)", "package_ndc": "68071-3719-9", "marketing_start_date": "20250114"}], "brand_name": "tizanidine", "product_id": "68071-3719_2bae2620-0abb-7e55-e063-6394a90ad47c", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "68071-3719", "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": "ANDA208187", "marketing_category": "ANDA", "marketing_start_date": "20210304", "listing_expiration_date": "20261231"}