ontralfy

Generic: tizanidine hydrochloride

Labeler: rosemont pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ontralfy
Generic Name tizanidine hydrochloride
Labeler rosemont pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/5mL

Manufacturer
Rosemont Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69528-310
Product ID 69528-310_4b1edc20-775b-bb26-e063-6394a90acd08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216190
Listing Expiration 2027-12-31
Marketing Start 2025-03-31

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 69528310
Hyphenated Format 69528-310

Supplemental Identifiers

RxCUI
2709432 2709438
UPC
0369528310160
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 ontralfy (source: ndc)
Generic Name tizanidine hydrochloride (source: ndc)
Application Number NDA216190 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (69528-310-16)
source: ndc

Packages (1)

69528-310-16 473 mL in 1 BOTTLE, PLASTIC (69528-310-16)

Ingredients (1)

tizanidine hydrochloride (2 mg/5mL)

Linked Drug Pages (1)

Ontralfy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b1edc20-775b-bb26-e063-6394a90acd08", "openfda": {"upc": ["0369528310160"], "unii": ["B53E3NMY5C"], "rxcui": ["2709432", "2709438"], "spl_set_id": ["7b88c338-c0b7-4c08-bef6-a4ffc2f25df7"], "manufacturer_name": ["Rosemont Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (69528-310-16)", "package_ndc": "69528-310-16", "marketing_start_date": "20251001"}], "brand_name": "Ontralfy", "product_id": "69528-310_4b1edc20-775b-bb26-e063-6394a90acd08", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "69528-310", "generic_name": "Tizanidine Hydrochloride", "labeler_name": "Rosemont Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ontralfy", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/5mL"}], "application_number": "NDA216190", "marketing_category": "NDA", "marketing_start_date": "20250331", "listing_expiration_date": "20271231"}