dextromethorphan hydrobromide

Generic: dextromethorphan hydrobromide

Labeler: softgel healthcare pvt ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan hydrobromide
Generic Name dextromethorphan hydrobromide
Labeler softgel healthcare pvt ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 15 mg/1

Manufacturer
Softgel Healthcare Pvt Ltd

Identifiers & Regulatory

Product NDC 35916-0461
Product ID 35916-0461_47df69f3-df76-5c0d-e063-6394a90af888
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2024-09-11

Pharmacologic Class

Classes
sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359160461
Hyphenated Format 35916-0461

Supplemental Identifiers

RxCUI
1090487
UNII
9D2RTI9KYH

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 dextromethorphan hydrobromide (source: ndc)
Generic Name dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0461-1)
  • 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0461-2)
  • 2 POUCH in 1 BOX (35916-0461-3) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
  • 2 BAG in 1 BOX (35916-0461-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (4)

35916-0461-1 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0461-1) 35916-0461-2 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0461-2) 35916-0461-3 2 POUCH in 1 BOX (35916-0461-3) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH 35916-0461-4 2 BAG in 1 BOX (35916-0461-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (1)

dextromethorphan hydrobromide (15 mg/1)

Linked Drug Pages (1)

Dextromethorphan Hydrobromide ndc-match (0.9)

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"}