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 2 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-455
Product ID 71610-455_2c6a6719-33e4-44e8-bce6-30c10ae156a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076533
Listing Expiration 2026-12-31
Marketing Start 2004-01-16

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 71610455
Hyphenated Format 71610-455

Supplemental Identifiers

RxCUI
313412
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 ANDA076533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 9000 TABLET in 1 BOTTLE (71610-455-09)
source: ndc

Packages (1)

71610-455-09 9000 TABLET in 1 BOTTLE (71610-455-09)

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": "2c6a6719-33e4-44e8-bce6-30c10ae156a6", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412"], "spl_set_id": ["d3b8d863-d13d-467c-97bf-5db9708036db"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET in 1 BOTTLE (71610-455-09)", "package_ndc": "71610-455-09", "marketing_start_date": "20200825"}], "brand_name": "tizanidine", "product_id": "71610-455_2c6a6719-33e4-44e8-bce6-30c10ae156a6", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "71610-455", "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": "2 mg/1"}], "application_number": "ANDA076533", "marketing_category": "ANDA", "marketing_start_date": "20040116", "listing_expiration_date": "20261231"}