sorbugen

Generic: dextromethorphan hydrobromide, glycerol guaiacolate

Labeler: kramer novis
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sorbugen
Generic Name dextromethorphan hydrobromide, glycerol guaiacolate
Labeler kramer novis
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 15 mg/7.5mL, guaifenesin 150 mg/7.5mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-660
Product ID 52083-660_796f9d98-f855-437f-9bca-bb322fa5b063
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-10-08

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52083660
Hyphenated Format 52083-660

Supplemental Identifiers

RxCUI
996520
UPC
0352083660160
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 sorbugen (source: ndc)
Generic Name dextromethorphan hydrobromide, glycerol guaiacolate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/7.5mL
  • 150 mg/7.5mL
source: ndc
Packaging
  • 480 mL in 1 BOTTLE (52083-660-16)
source: ndc

Packages (1)

52083-660-16 480 mL in 1 BOTTLE (52083-660-16)

Ingredients (2)

dextromethorphan hydrobromide (15 mg/7.5mL) guaifenesin (150 mg/7.5mL)

Linked Drug Pages (1)

Sorbugen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "796f9d98-f855-437f-9bca-bb322fa5b063", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0352083660160"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["a8f2a2d7-0360-45a8-9635-c852f4a7d7ba"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Kramer Novis"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "480 mL in 1 BOTTLE (52083-660-16)", "package_ndc": "52083-660-16", "marketing_start_date": "20141008"}], "brand_name": "Sorbugen", "product_id": "52083-660_796f9d98-f855-437f-9bca-bb322fa5b063", "dosage_form": "SYRUP", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "52083-660", "generic_name": "dextromethorphan hydrobromide, glycerol guaiacolate", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sorbugen", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/7.5mL"}, {"name": "GUAIFENESIN", "strength": "150 mg/7.5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141008", "listing_expiration_date": "20261231"}