tizanidine

Generic: tizanidine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-602
Product ID 72189-602_2d4108dc-4f74-69fb-e063-6294a90a10f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076416
Listing Expiration 2026-12-31
Marketing Start 2024-12-31

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 72189602
Hyphenated Format 72189-602

Supplemental Identifiers

RxCUI
313413
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 ANDA076416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72189-602-30)
  • 60 TABLET in 1 BOTTLE (72189-602-60)
  • 90 TABLET in 1 BOTTLE (72189-602-90)
source: ndc

Packages (3)

72189-602-30 30 TABLET in 1 BOTTLE (72189-602-30) 72189-602-60 60 TABLET in 1 BOTTLE (72189-602-60) 72189-602-90 90 TABLET in 1 BOTTLE (72189-602-90)

Ingredients (1)

tizanidine hydrochloride (4 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": "2d4108dc-4f74-69fb-e063-6294a90a10f8", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["2a91884a-39c3-f7ac-e063-6394a90ade14"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-602-30)", "package_ndc": "72189-602-30", "marketing_start_date": "20241231"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-602-60)", "package_ndc": "72189-602-60", "marketing_start_date": "20241231"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-602-90)", "package_ndc": "72189-602-90", "marketing_start_date": "20241231"}], "brand_name": "Tizanidine", "product_id": "72189-602_2d4108dc-4f74-69fb-e063-6294a90a10f8", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72189-602", "generic_name": "Tizanidine", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076416", "marketing_category": "ANDA", "marketing_start_date": "20241231", "listing_expiration_date": "20261231"}