dextromethorphan hbr 15 mg

Generic: dextromethorphan hbr

Labeler: humanwell puracap pharmaceutical (wuhan), ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan hbr 15 mg
Generic Name dextromethorphan hbr
Labeler humanwell puracap pharmaceutical (wuhan), ltd.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 15 mg/1

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Identifiers & Regulatory

Product NDC 53345-011
Product ID 53345-011_2767cee1-e298-26d6-e063-6294a90ab8b8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-01-30

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 53345011
Hyphenated Format 53345-011

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 hbr 15 mg (source: ndc)
Generic Name dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 1 BAG in 1 BOX (53345-011-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

53345-011-01 1 BAG in 1 BOX (53345-011-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (1)

dextromethorphan hydrobromide (15 mg/1)

Linked Drug Pages (1)

Dextromethorphan HBr 15 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2767cee1-e298-26d6-e063-6294a90ab8b8", "openfda": {"unii": ["9D2RTI9KYH"], "rxcui": ["1090487"], "spl_set_id": ["028b025e-2dde-4bef-ba7b-61774e855b4b"], "manufacturer_name": ["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-011-01)  / 12000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-011-01", "marketing_start_date": "20140130"}], "brand_name": "Dextromethorphan HBr 15 mg", "product_id": "53345-011_2767cee1-e298-26d6-e063-6294a90ab8b8", "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": "53345-011", "generic_name": "Dextromethorphan HBr", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dextromethorphan HBr 15 mg", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140130", "listing_expiration_date": "20261231"}