tizanidne hydrochloride

Generic: tizanidne hydrochloride

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidne hydrochloride
Generic Name tizanidne hydrochloride
Labeler quality care products, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 6 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-076
Product ID 83008-076_93f7f4fa-262e-44ef-b2bd-a28afa670e4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212196
Marketing Start 2024-08-13
Marketing End 2026-03-31

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 83008076
Hyphenated Format 83008-076

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 tizanidne hydrochloride (source: ndc)
Generic Name tizanidne hydrochloride (source: ndc)
Application Number ANDA212196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (83008-076-30)
source: ndc

Packages (1)

83008-076-30 30 CAPSULE in 1 BOTTLE (83008-076-30)

Ingredients (1)

tizanidine hydrochloride (6 mg/1)

Linked Drug Pages (1)

Tizanidne hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "93f7f4fa-262e-44ef-b2bd-a28afa670e4b", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484"], "spl_set_id": ["64924e9d-01c3-406e-a251-200ce0d7d88b"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (83008-076-30)", "package_ndc": "83008-076-30", "marketing_end_date": "20260331", "marketing_start_date": "20240813"}], "brand_name": "Tizanidne hydrochloride", "product_id": "83008-076_93f7f4fa-262e-44ef-b2bd-a28afa670e4b", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "83008-076", "generic_name": "Tizanidne Hydrochloride", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidne hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA212196", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20240813"}