tizanidine

Generic: tizanidine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-775
Product ID 68084-775_35bfea02-ba73-d8c2-e063-6394a90a5c9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076286
Listing Expiration 2026-12-31
Marketing Start 2016-01-25

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 68084775
Hyphenated Format 68084-775

Supplemental Identifiers

RxCUI
313412 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 ANDA076286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-775-25) / 1 TABLET in 1 BLISTER PACK (68084-775-95)
source: ndc

Packages (1)

68084-775-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-775-25) / 1 TABLET in 1 BLISTER PACK (68084-775-95)

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": "35bfea02-ba73-d8c2-e063-6394a90a5c9f", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["3670f9e3-988d-48e6-9df0-d403d699e08a"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-775-25)  / 1 TABLET in 1 BLISTER PACK (68084-775-95)", "package_ndc": "68084-775-25", "marketing_start_date": "20160125"}], "brand_name": "Tizanidine", "product_id": "68084-775_35bfea02-ba73-d8c2-e063-6394a90a5c9f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "68084-775", "generic_name": "Tizanidine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA076286", "marketing_category": "ANDA", "marketing_start_date": "20160125", "listing_expiration_date": "20261231"}