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 72789-325
Product ID 72789-325_40bb3383-082a-7a68-e063-6394a90a8da3
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 72789325
Hyphenated Format 72789-325

Supplemental Identifiers

RxCUI
313412 313413
UPC
0372789326771 0372789325309
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
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-325-30)
  • 150 TABLET in 1 BOTTLE, PLASTIC (72789-325-77)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-325-90)
source: ndc

Packages (3)

72789-325-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-325-30) 72789-325-77 150 TABLET in 1 BOTTLE, PLASTIC (72789-325-77) 72789-325-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-325-90)

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": "40bb3383-082a-7a68-e063-6394a90a8da3", "openfda": {"upc": ["0372789326771", "0372789325309"], "unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["fd16a25c-67b6-ae6c-e053-6394a90aeee0"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-325-30)", "package_ndc": "72789-325-30", "marketing_start_date": "20230601"}, {"sample": false, "description": "150 TABLET in 1 BOTTLE, PLASTIC (72789-325-77)", "package_ndc": "72789-325-77", "marketing_start_date": "20230601"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-325-90)", "package_ndc": "72789-325-90", "marketing_start_date": "20230602"}], "brand_name": "Tizanidine", "product_id": "72789-325_40bb3383-082a-7a68-e063-6394a90a8da3", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72789-325", "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"}