tizanidine

Generic: tizanidine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-613
Product ID 67877-613_e9f19258-b62c-471d-82c4-1e2bdc030833
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211798
Listing Expiration 2026-12-31
Marketing Start 2019-01-27

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 67877613
Hyphenated Format 67877-613

Supplemental Identifiers

RxCUI
313412 313413
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 ANDA211798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (67877-613-05)
  • 150 TABLET in 1 BOTTLE (67877-613-15)
source: ndc

Packages (2)

67877-613-05 500 TABLET in 1 BOTTLE (67877-613-05) 67877-613-15 150 TABLET in 1 BOTTLE (67877-613-15)

Ingredients (1)

tizanidine hydrochloride (2 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": "e9f19258-b62c-471d-82c4-1e2bdc030833", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["72f25135-1333-4e52-83f5-7df7d90e68bb"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-613-05)", "package_ndc": "67877-613-05", "marketing_start_date": "20190127"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (67877-613-15)", "package_ndc": "67877-613-15", "marketing_start_date": "20190127"}], "brand_name": "Tizanidine", "product_id": "67877-613_e9f19258-b62c-471d-82c4-1e2bdc030833", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "67877-613", "generic_name": "Tizanidine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA211798", "marketing_category": "ANDA", "marketing_start_date": "20190127", "listing_expiration_date": "20261231"}