tizanidine hydrochloride

Generic: tizanidine hydrochloride

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

Drug Facts

Product Profile

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

tizanidine hydrochloride 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-507
Product ID 72789-507_3ba1fda2-ab86-5dd7-e063-6294a90a5364
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213798
Listing Expiration 2026-12-31
Marketing Start 2020-05-27

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 72789507
Hyphenated Format 72789-507

Supplemental Identifiers

RxCUI
485485
UPC
0372789507774
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 hydrochloride (source: ndc)
Generic Name tizanidine hydrochloride (source: ndc)
Application Number ANDA213798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 150 CAPSULE in 1 BOTTLE, PLASTIC (72789-507-77)
source: ndc

Packages (1)

72789-507-77 150 CAPSULE in 1 BOTTLE, PLASTIC (72789-507-77)

Ingredients (1)

tizanidine hydrochloride (4 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": "3ba1fda2-ab86-5dd7-e063-6294a90a5364", "openfda": {"upc": ["0372789507774"], "unii": ["B53E3NMY5C"], "rxcui": ["485485"], "spl_set_id": ["d7d5dce0-f8a2-404d-9e87-e2235f5d3268"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "150 CAPSULE in 1 BOTTLE, PLASTIC (72789-507-77)", "package_ndc": "72789-507-77", "marketing_start_date": "20250516"}], "brand_name": "tizanidine hydrochloride", "product_id": "72789-507_3ba1fda2-ab86-5dd7-e063-6294a90a5364", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "72789-507", "generic_name": "tizanidine hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tizanidine hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA213798", "marketing_category": "ANDA", "marketing_start_date": "20200527", "listing_expiration_date": "20261231"}