tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine hydrochloride
Generic Name tizanidine hydrochloride
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 6 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0448
Product ID 80425-0448_26f91e07-2e12-1faf-e063-6394a90a0eb4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210267
Listing Expiration 2026-12-31
Marketing Start 2024-10-29

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 804250448
Hyphenated Format 80425-0448

Supplemental Identifiers

RxCUI
485484
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 hydrochloride (source: ndc)
Generic Name tizanidine hydrochloride (source: ndc)
Application Number ANDA210267 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-1)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-2)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-3)
source: ndc

Packages (3)

80425-0448-1 30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-1) 80425-0448-2 60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-2) 80425-0448-3 90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-3)

Ingredients (1)

tizanidine hydrochloride (6 mg/1)

Linked Drug Pages (1)

TIZANIDINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26f91e07-2e12-1faf-e063-6394a90a0eb4", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484"], "spl_set_id": ["26f8f233-5dc2-0013-e063-6394a90ab0f5"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-1)", "package_ndc": "80425-0448-1", "marketing_start_date": "20241029"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-2)", "package_ndc": "80425-0448-2", "marketing_start_date": "20241029"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-3)", "package_ndc": "80425-0448-3", "marketing_start_date": "20241029"}], "brand_name": "TIZANIDINE HYDROCHLORIDE", "product_id": "80425-0448_26f91e07-2e12-1faf-e063-6394a90a0eb4", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "80425-0448", "generic_name": "tizanidine hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIZANIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA210267", "marketing_category": "ANDA", "marketing_start_date": "20241029", "listing_expiration_date": "20261231"}