tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine hydrochloride
Generic Name tizanidine hydrochloride
Labeler actavis pharma, inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2788
Product ID 0591-2788_5c8f8c47-4f62-4954-8135-957c967dd7cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021447
Listing Expiration 2026-12-31
Marketing Start 2012-02-06

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 05912788
Hyphenated Format 0591-2788

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 NDA021447 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2788-86)
source: ndc

Packages (1)

0591-2788-86 150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2788-86)

Ingredients (1)

tizanidine hydrochloride (2 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": "5c8f8c47-4f62-4954-8135-957c967dd7cb", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484", "485485", "485486"], "spl_set_id": ["cb8b01b3-bcec-4762-9d67-0db018ef6b22"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2788-86)", "package_ndc": "0591-2788-86", "marketing_start_date": "20120206"}], "brand_name": "tizanidine hydrochloride", "product_id": "0591-2788_5c8f8c47-4f62-4954-8135-957c967dd7cb", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "0591-2788", "generic_name": "tizanidine hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "NDA021447", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20120206", "listing_expiration_date": "20261231"}