tizanidine

Generic: tizanidine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-503
Product ID 57664-503_5e8ef5b3-9f58-46a7-833c-31ef018ea9a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076416
Listing Expiration 2026-12-31
Marketing Start 2003-12-11

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 57664503
Hyphenated Format 57664-503

Supplemental Identifiers

RxCUI
313412 313413
UNII
B53E3NMY5C

Packaging Origin

Original Packager
true

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
  • 1000 TABLET in 1 BOTTLE (57664-503-18)
  • 150 TABLET in 1 BOTTLE (57664-503-89)
source: ndc

Packages (2)

57664-503-18 1000 TABLET in 1 BOTTLE (57664-503-18) 57664-503-89 150 TABLET in 1 BOTTLE (57664-503-89)

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": "5e8ef5b3-9f58-46a7-833c-31ef018ea9a0", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["4659df31-8b89-4eff-9d86-7b7e38de416b"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (57664-503-18)", "package_ndc": "57664-503-18", "marketing_start_date": "20031211"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (57664-503-89)", "package_ndc": "57664-503-89", "marketing_start_date": "20031211"}], "brand_name": "Tizanidine", "product_id": "57664-503_5e8ef5b3-9f58-46a7-833c-31ef018ea9a0", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "57664-503", "generic_name": "Tizanidine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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": "20031211", "listing_expiration_date": "20261231"}