tizanidine

Generic: tizanidine

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

Drug Facts

Product Profile

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

tizanidine hydrochloride 4 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1336
Product ID 70771-1336_d046bff9-82fd-4905-ba58-b955f5a608d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208187
Listing Expiration 2026-12-31
Marketing Start 2018-09-13

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 707711336
Hyphenated Format 70771-1336

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 ANDA208187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1336-0)
  • 30 TABLET in 1 BOTTLE (70771-1336-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1336-4) / 10 TABLET in 1 BLISTER PACK (70771-1336-2)
  • 150 TABLET in 1 BOTTLE (70771-1336-8)
source: ndc

Packages (4)

70771-1336-0 1000 TABLET in 1 BOTTLE (70771-1336-0) 70771-1336-3 30 TABLET in 1 BOTTLE (70771-1336-3) 70771-1336-4 10 BLISTER PACK in 1 CARTON (70771-1336-4) / 10 TABLET in 1 BLISTER PACK (70771-1336-2) 70771-1336-8 150 TABLET in 1 BOTTLE (70771-1336-8)

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": "d046bff9-82fd-4905-ba58-b955f5a608d9", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["89105a78-badb-469e-966e-195fa3a53f0a"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1336-0)", "package_ndc": "70771-1336-0", "marketing_start_date": "20180913"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1336-3)", "package_ndc": "70771-1336-3", "marketing_start_date": "20180913"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1336-4)  / 10 TABLET in 1 BLISTER PACK (70771-1336-2)", "package_ndc": "70771-1336-4", "marketing_start_date": "20180913"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE (70771-1336-8)", "package_ndc": "70771-1336-8", "marketing_start_date": "20180913"}], "brand_name": "tizanidine", "product_id": "70771-1336_d046bff9-82fd-4905-ba58-b955f5a608d9", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70771-1336", "generic_name": "tizanidine", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA208187", "marketing_category": "ANDA", "marketing_start_date": "20180913", "listing_expiration_date": "20261231"}