Package 69528-310-16

Brand: ontralfy

Generic: tizanidine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 69528-310-16
Digits Only 6952831016
Product NDC 69528-310
Product ID 69528-310_4b1edc20-775b-bb26-e063-6394a90acd08
Description

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

Marketing

Marketing Status
Marketed Since 2025-10-01
Brand ontralfy
Generic tizanidine hydrochloride
Sample Package No

Linked Drug Pages (1)

Ontralfy ndc-match (0.95)

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"}