tizanidine

Generic: tizanidine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3658
Product ID 70518-3658_48bed60b-b71a-891d-e063-6394a90aa6c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076286
Listing Expiration 2027-12-31
Marketing Start 2023-02-23

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 705183658
Hyphenated Format 70518-3658

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 ANDA076286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3658-0)
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3658-1)
  • 60 TABLET in 1 BOTTLE, PLASTIC (70518-3658-2)
  • 15 TABLET in 1 BOTTLE, PLASTIC (70518-3658-3)
source: ndc

Packages (4)

70518-3658-0 30 TABLET in 1 BLISTER PACK (70518-3658-0) 70518-3658-1 90 TABLET in 1 BOTTLE, PLASTIC (70518-3658-1) 70518-3658-2 60 TABLET in 1 BOTTLE, PLASTIC (70518-3658-2) 70518-3658-3 15 TABLET in 1 BOTTLE, PLASTIC (70518-3658-3)

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": "48bed60b-b71a-891d-e063-6394a90aa6c3", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["9bcc7f09-d2b5-4602-aaf3-5410b55ce275"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3658-0)", "package_ndc": "70518-3658-0", "marketing_start_date": "20230223"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3658-1)", "package_ndc": "70518-3658-1", "marketing_start_date": "20230508"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (70518-3658-2)", "package_ndc": "70518-3658-2", "marketing_start_date": "20230619"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (70518-3658-3)", "package_ndc": "70518-3658-3", "marketing_start_date": "20230711"}], "brand_name": "Tizanidine", "product_id": "70518-3658_48bed60b-b71a-891d-e063-6394a90aa6c3", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70518-3658", "generic_name": "Tizanidine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076286", "marketing_category": "ANDA", "marketing_start_date": "20230223", "listing_expiration_date": "20271231"}