tizanidine

Generic: tizanidine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-673
Product ID 63187-673_2b2e33aa-55ad-4969-85d1-9cbfb62cabbb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076416
Listing Expiration 2026-12-31
Marketing Start 2003-12-11

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 63187673
Hyphenated Format 63187-673

Supplemental Identifiers

RxCUI
313413
UPC
0363187673307
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 ANDA076416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BOTTLE (63187-673-14)
  • 30 TABLET in 1 BOTTLE (63187-673-30)
  • 60 TABLET in 1 BOTTLE (63187-673-60)
  • 90 TABLET in 1 BOTTLE (63187-673-90)
source: ndc

Packages (4)

63187-673-14 14 TABLET in 1 BOTTLE (63187-673-14) 63187-673-30 30 TABLET in 1 BOTTLE (63187-673-30) 63187-673-60 60 TABLET in 1 BOTTLE (63187-673-60) 63187-673-90 90 TABLET in 1 BOTTLE (63187-673-90)

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": "2b2e33aa-55ad-4969-85d1-9cbfb62cabbb", "openfda": {"upc": ["0363187673307"], "unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["76dc85bd-3cde-4940-a99b-663b70bf9f54"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET in 1 BOTTLE (63187-673-14)", "package_ndc": "63187-673-14", "marketing_start_date": "20220105"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-673-30)", "package_ndc": "63187-673-30", "marketing_start_date": "20181201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-673-60)", "package_ndc": "63187-673-60", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-673-90)", "package_ndc": "63187-673-90", "marketing_start_date": "20181201"}], "brand_name": "Tizanidine", "product_id": "63187-673_2b2e33aa-55ad-4969-85d1-9cbfb62cabbb", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "63187-673", "generic_name": "Tizanidine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076416", "marketing_category": "ANDA", "marketing_start_date": "20031211", "listing_expiration_date": "20261231"}