tizanidine

Generic: tizanidine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-864
Product ID 71610-864_390c9dff-6c5c-7bfa-e063-6294a90ad843
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 71610864
Hyphenated Format 71610-864

Supplemental Identifiers

RxCUI
313413
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
  • 6000 TABLET in 1 BOTTLE (71610-864-16)
  • 30 TABLET in 1 BOTTLE (71610-864-30)
  • 60 TABLET in 1 BOTTLE (71610-864-53)
  • 90 TABLET in 1 BOTTLE (71610-864-60)
  • 180 TABLET in 1 BOTTLE (71610-864-80)
source: ndc

Packages (5)

71610-864-16 6000 TABLET in 1 BOTTLE (71610-864-16) 71610-864-30 30 TABLET in 1 BOTTLE (71610-864-30) 71610-864-53 60 TABLET in 1 BOTTLE (71610-864-53) 71610-864-60 90 TABLET in 1 BOTTLE (71610-864-60) 71610-864-80 180 TABLET in 1 BOTTLE (71610-864-80)

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": "390c9dff-6c5c-7bfa-e063-6294a90ad843", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["25db7cc0-604c-3d6b-e063-6394a90a337f"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "6000 TABLET in 1 BOTTLE (71610-864-16)", "package_ndc": "71610-864-16", "marketing_start_date": "20241029"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-864-30)", "package_ndc": "71610-864-30", "marketing_start_date": "20250702"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-864-53)", "package_ndc": "71610-864-53", "marketing_start_date": "20250124"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-864-60)", "package_ndc": "71610-864-60", "marketing_start_date": "20250124"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-864-80)", "package_ndc": "71610-864-80", "marketing_start_date": "20250131"}], "brand_name": "Tizanidine", "product_id": "71610-864_390c9dff-6c5c-7bfa-e063-6294a90ad843", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "71610-864", "generic_name": "Tizanidine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}