tizanidine

Generic: tizanidine

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-172
Product ID 16714-172_a9995022-1f3f-f0dd-9672-60b074bfca01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076286
Listing Expiration 2026-12-31
Marketing Start 2021-06-15

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 16714172
Hyphenated Format 16714-172

Supplemental Identifiers

RxCUI
313412 313413
UPC
0316714171012 0316714172019
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 ANDA076286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 150 TABLET in 1 BOTTLE (16714-172-01)
  • 1000 TABLET in 1 BOTTLE (16714-172-02)
source: ndc

Packages (2)

16714-172-01 150 TABLET in 1 BOTTLE (16714-172-01) 16714-172-02 1000 TABLET in 1 BOTTLE (16714-172-02)

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": "a9995022-1f3f-f0dd-9672-60b074bfca01", "openfda": {"upc": ["0316714171012", "0316714172019"], "unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["eed74219-9d4a-fecd-1bb9-ad6c01ad3e9d"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 TABLET in 1 BOTTLE (16714-172-01)", "package_ndc": "16714-172-01", "marketing_start_date": "20210615"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (16714-172-02)", "package_ndc": "16714-172-02", "marketing_start_date": "20210615"}], "brand_name": "Tizanidine", "product_id": "16714-172_a9995022-1f3f-f0dd-9672-60b074bfca01", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "16714-172", "generic_name": "Tizanidine", "labeler_name": "NorthStar Rx LLC", "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": "20210615", "listing_expiration_date": "20261231"}