tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine hydrochloride
Generic Name tizanidine hydrochloride
Labeler nivagen pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 6 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-209
Product ID 75834-209_359eaf8b-a8f7-4493-ba61-98e106bcc3d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210021
Listing Expiration 2026-12-31
Marketing Start 2019-09-26

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 75834209
Hyphenated Format 75834-209

Supplemental Identifiers

RxCUI
485484 485485 485486
UPC
0375834208152 0375834209159
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 ANDA210021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 150 CAPSULE in 1 BOTTLE (75834-209-15)
source: ndc

Packages (1)

75834-209-15 150 CAPSULE in 1 BOTTLE (75834-209-15)

Ingredients (1)

tizanidine hydrochloride (6 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": "359eaf8b-a8f7-4493-ba61-98e106bcc3d5", "openfda": {"upc": ["0375834208152", "0375834209159"], "unii": ["B53E3NMY5C"], "rxcui": ["485484", "485485", "485486"], "spl_set_id": ["c4a5b305-4265-4f90-a9ff-c16c0b936a06"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 CAPSULE in 1 BOTTLE (75834-209-15)", "package_ndc": "75834-209-15", "marketing_start_date": "20190926"}], "brand_name": "TIZANIDINE HYDROCHLORIDE", "product_id": "75834-209_359eaf8b-a8f7-4493-ba61-98e106bcc3d5", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "75834-209", "generic_name": "TIZANIDINE HYDROCHLORIDE", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIZANIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA210021", "marketing_category": "ANDA", "marketing_start_date": "20190926", "listing_expiration_date": "20261231"}