Package 35916-0461-2

Brand: dextromethorphan hydrobromide

Generic: dextromethorphan hydrobromide
NDC Package

Package Facts

Identity

Package NDC 35916-0461-2
Digits Only 3591604612
Product NDC 35916-0461
Description

1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0461-2)

Marketing

Marketing Status
Marketed Since 2025-03-18
Brand dextromethorphan hydrobromide
Generic dextromethorphan hydrobromide
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47df69f3-df76-5c0d-e063-6394a90af888", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1090487"], "spl_set_id": ["20f7c1a9-fc4d-1f51-e063-6394a90a8be3"], "manufacturer_name": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0461-1)", "package_ndc": "35916-0461-1", "marketing_start_date": "20240911"}, {"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0461-2)", "package_ndc": "35916-0461-2", "marketing_start_date": "20250318"}, {"sample": false, "description": "2 POUCH in 1 BOX (35916-0461-3)  / 3000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "35916-0461-3", "marketing_start_date": "20250717"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-0461-4)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-0461-4", "marketing_start_date": "20260112"}], "brand_name": "Dextromethorphan Hydrobromide", "product_id": "35916-0461_47df69f3-df76-5c0d-e063-6394a90af888", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "35916-0461", "generic_name": "Dextromethorphan Hydrobromide", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240911", "listing_expiration_date": "20271231"}