tizanidine

Generic: tizanidine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-327
Product ID 72789-327_40bb3624-175c-7967-e063-6394a90af2dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076416
Listing Expiration 2026-12-31
Marketing Start 2003-12-11

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 72789327
Hyphenated Format 72789-327

Supplemental Identifiers

RxCUI
313413
UPC
0372789327204
UNII
B53E3NMY5C

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 ANDA076416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE, PLASTIC (72789-327-20)
source: ndc

Packages (1)

72789-327-20 20 TABLET in 1 BOTTLE, PLASTIC (72789-327-20)

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": "40bb3624-175c-7967-e063-6394a90af2dd", "openfda": {"upc": ["0372789327204"], "unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["fdf4f09d-4537-a438-e053-6394a90a573d"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (72789-327-20)", "package_ndc": "72789-327-20", "marketing_start_date": "20230612"}], "brand_name": "Tizanidine", "product_id": "72789-327_40bb3624-175c-7967-e063-6394a90af2dd", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72789-327", "generic_name": "Tizanidine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076416", "marketing_category": "ANDA", "marketing_start_date": "20031211", "listing_expiration_date": "20261231"}