tizanidine

Generic: tizanidine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tizanidine hydrochloride 4 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6418
Product ID 0904-6418_922b5a2a-5a35-41e0-927c-836f2ff11523
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076533
Listing Expiration 2026-12-31
Marketing Start 2014-10-01

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 09046418
Hyphenated Format 0904-6418

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 ANDA076533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6418-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6418-61 100 BLISTER PACK in 1 CARTON (0904-6418-61) / 1 TABLET in 1 BLISTER PACK

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": "922b5a2a-5a35-41e0-927c-836f2ff11523", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["d24e0cda-a22f-404f-b861-f85090cef099"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6418-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6418-61", "marketing_start_date": "20141001"}], "brand_name": "tizanidine", "product_id": "0904-6418_922b5a2a-5a35-41e0-927c-836f2ff11523", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "0904-6418", "generic_name": "tizanidine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076533", "marketing_category": "ANDA", "marketing_start_date": "20141001", "listing_expiration_date": "20261231"}