tizanidine

Generic: tizanidine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-658
Product ID 64980-658_356b3e79-d47b-467a-af62-2adca35f1a2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218920
Listing Expiration 2026-12-31
Marketing Start 2024-12-15

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 64980658
Hyphenated Format 64980-658

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 ANDA218920 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (64980-658-03)
  • 1000 TABLET in 1 BOTTLE (64980-658-10)
  • 150 TABLET in 1 BOTTLE (64980-658-15)
source: ndc

Packages (3)

64980-658-03 30 TABLET in 1 BOTTLE (64980-658-03) 64980-658-10 1000 TABLET in 1 BOTTLE (64980-658-10) 64980-658-15 150 TABLET in 1 BOTTLE (64980-658-15)

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": "356b3e79-d47b-467a-af62-2adca35f1a2f", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["433ac98f-ac22-44ad-a8b4-5db5560b9d0f"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (64980-658-03)", "package_ndc": "64980-658-03", "marketing_start_date": "20241215"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (64980-658-10)", "package_ndc": "64980-658-10", "marketing_start_date": "20241215"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (64980-658-15)", "package_ndc": "64980-658-15", "marketing_start_date": "20241215"}], "brand_name": "tizanidine", "product_id": "64980-658_356b3e79-d47b-467a-af62-2adca35f1a2f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "64980-658", "generic_name": "tizanidine", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA218920", "marketing_category": "ANDA", "marketing_start_date": "20241215", "listing_expiration_date": "20261231"}