tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine hydrochloride
Generic Name tizanidine hydrochloride
Labeler zydus lifesciences limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1068
Product ID 70771-1068_e5aa06ec-9ceb-4c1c-9334-90bef0d9366f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208622
Listing Expiration 2027-12-31
Marketing Start 2017-04-27

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 707711068
Hyphenated Format 70771-1068

Supplemental Identifiers

RxCUI
485484 485485 485486
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 hydrochloride (source: ndc)
Generic Name tizanidine hydrochloride (source: ndc)
Application Number ANDA208622 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (70771-1068-4) / 10 CAPSULE in 1 BLISTER PACK
  • 500 CAPSULE in 1 BOTTLE (70771-1068-5)
  • 150 CAPSULE in 1 BOTTLE (70771-1068-8)
source: ndc

Packages (3)

70771-1068-4 10 BLISTER PACK in 1 CARTON (70771-1068-4) / 10 CAPSULE in 1 BLISTER PACK 70771-1068-5 500 CAPSULE in 1 BOTTLE (70771-1068-5) 70771-1068-8 150 CAPSULE in 1 BOTTLE (70771-1068-8)

Ingredients (1)

tizanidine hydrochloride (4 mg/1)

Linked Drug Pages (1)

tizanidine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e5aa06ec-9ceb-4c1c-9334-90bef0d9366f", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484", "485485", "485486"], "spl_set_id": ["5f4889d1-1387-4c90-9b76-00beda3c1683"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1068-4)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "70771-1068-4", "marketing_start_date": "20170427"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (70771-1068-5)", "package_ndc": "70771-1068-5", "marketing_start_date": "20170427"}, {"sample": false, "description": "150 CAPSULE in 1 BOTTLE (70771-1068-8)", "package_ndc": "70771-1068-8", "marketing_start_date": "20170427"}], "brand_name": "tizanidine hydrochloride", "product_id": "70771-1068_e5aa06ec-9ceb-4c1c-9334-90bef0d9366f", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70771-1068", "generic_name": "tizanidine hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA208622", "marketing_category": "ANDA", "marketing_start_date": "20170427", "listing_expiration_date": "20271231"}