presgen b

Generic: dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name presgen b
Generic Name dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride
Labeler kramer novis
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

brompheniramine maleate 4 mg/5mL, dextromethorphan hydrobromide 20 mg/5mL, phenylephrine hydrochloride 10 mg/5mL

Manufacturer
KRAMER NOVIS

Identifiers & Regulatory

Product NDC 52083-637
Product ID 52083-637_0e6e64a1-f9ee-47cb-8ee7-23800b7fb564
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2011-03-29

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52083637
Hyphenated Format 52083-637

Supplemental Identifiers

RxCUI
1148155
UPC
0352083637162
UNII
IXA7C9ZN03 9D2RTI9KYH 04JA59TNSJ

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 presgen b (source: ndc)
Generic Name dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
  • 20 mg/5mL
  • 10 mg/5mL
source: ndc
Packaging
  • 480 mL in 1 BOTTLE (52083-637-16)
source: ndc

Packages (1)

52083-637-16 480 mL in 1 BOTTLE (52083-637-16)

Ingredients (3)

brompheniramine maleate (4 mg/5mL) dextromethorphan hydrobromide (20 mg/5mL) phenylephrine hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

Presgen B ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0e6e64a1-f9ee-47cb-8ee7-23800b7fb564", "openfda": {"upc": ["0352083637162"], "unii": ["IXA7C9ZN03", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1148155"], "spl_set_id": ["5befa829-32bd-4978-8a0e-1d6513ff37a4"], "manufacturer_name": ["KRAMER NOVIS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "480 mL in 1 BOTTLE (52083-637-16)", "package_ndc": "52083-637-16", "marketing_start_date": "20110329"}], "brand_name": "Presgen B", "product_id": "52083-637_0e6e64a1-f9ee-47cb-8ee7-23800b7fb564", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "52083-637", "generic_name": "dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride", "labeler_name": "KRAMER NOVIS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Presgen B", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "4 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110329", "listing_expiration_date": "20261231"}