tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine hydrochloride
Generic Name tizanidine hydrochloride
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-901
Product ID 76420-901_4647720a-9159-6041-e063-6294a90a54f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212196
Listing Expiration 2026-12-31
Marketing Start 2019-03-29

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 76420901
Hyphenated Format 76420-901

Supplemental Identifiers

RxCUI
485484 485485 485486
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 ANDA212196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (76420-901-01) / 10 CAPSULE in 1 BLISTER PACK
  • 500 CAPSULE in 1 BOTTLE (76420-901-05)
  • 10 CAPSULE in 1 BOTTLE (76420-901-10)
  • 150 CAPSULE in 1 BOTTLE (76420-901-15)
  • 20 CAPSULE in 1 BOTTLE (76420-901-20)
  • 30 CAPSULE in 1 BOTTLE (76420-901-30)
  • 60 CAPSULE in 1 BOTTLE (76420-901-60)
  • 90 CAPSULE in 1 BOTTLE (76420-901-90)
source: ndc

Packages (8)

76420-901-01 1 BLISTER PACK in 1 CARTON (76420-901-01) / 10 CAPSULE in 1 BLISTER PACK 76420-901-05 500 CAPSULE in 1 BOTTLE (76420-901-05) 76420-901-10 10 CAPSULE in 1 BOTTLE (76420-901-10) 76420-901-15 150 CAPSULE in 1 BOTTLE (76420-901-15) 76420-901-20 20 CAPSULE in 1 BOTTLE (76420-901-20) 76420-901-30 30 CAPSULE in 1 BOTTLE (76420-901-30) 76420-901-60 60 CAPSULE in 1 BOTTLE (76420-901-60) 76420-901-90 90 CAPSULE in 1 BOTTLE (76420-901-90)

Ingredients (1)

tizanidine hydrochloride (4 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": "4647720a-9159-6041-e063-6294a90a54f1", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484", "485485", "485486"], "spl_set_id": ["07b8db58-d037-477e-a62f-025e8a5afcb4"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (76420-901-01)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "76420-901-01", "marketing_start_date": "20250128"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (76420-901-05)", "package_ndc": "76420-901-05", "marketing_start_date": "20250128"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (76420-901-10)", "package_ndc": "76420-901-10", "marketing_start_date": "20250128"}, {"sample": false, "description": "150 CAPSULE in 1 BOTTLE (76420-901-15)", "package_ndc": "76420-901-15", "marketing_start_date": "20250128"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (76420-901-20)", "package_ndc": "76420-901-20", "marketing_start_date": "20250128"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-901-30)", "package_ndc": "76420-901-30", "marketing_start_date": "20250128"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-901-60)", "package_ndc": "76420-901-60", "marketing_start_date": "20250128"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-901-90)", "package_ndc": "76420-901-90", "marketing_start_date": "20250128"}], "brand_name": "Tizanidine Hydrochloride", "product_id": "76420-901_4647720a-9159-6041-e063-6294a90a54f1", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "76420-901", "generic_name": "Tizanidine Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine Hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA212196", "marketing_category": "ANDA", "marketing_start_date": "20190329", "listing_expiration_date": "20261231"}