rynex pse

Generic: brompheniramine maleate and pseudoephedrine hydrochloride

Labeler: edwards pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name rynex pse
Generic Name brompheniramine maleate and pseudoephedrine hydrochloride
Labeler edwards pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

brompheniramine maleate 1 mg/5mL, pseudoephedrine hydrochloride 15 mg/5mL

Manufacturer
EDWARDS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 0485-0206
Product ID 0485-0206_4c48242c-1746-1a49-e063-6294a90ac81d
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2027-12-31
Marketing Start 2011-03-07

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04850206
Hyphenated Format 0485-0206

Supplemental Identifiers

RxCUI
1098498
UNII
IXA7C9ZN03 6V9V2RYJ8N

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 rynex pse (source: ndc)
Generic Name brompheniramine maleate and pseudoephedrine hydrochloride (source: ndc)
Application Number M012 (source: label)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/5mL
  • 15 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (0485-0206-16)
source: ndc

Packages (1)

0485-0206-16 473 mL in 1 BOTTLE, PLASTIC (0485-0206-16)

Ingredients (2)

brompheniramine maleate (1 mg/5mL) pseudoephedrine hydrochloride (15 mg/5mL)

Linked Drug Pages (1)

RYNEX PSE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c48242c-1746-1a49-e063-6294a90ac81d", "openfda": {"unii": ["IXA7C9ZN03", "6V9V2RYJ8N"], "rxcui": ["1098498"], "spl_set_id": ["2f2d9b5a-f66b-4928-8d43-402ef9efcfdf"], "manufacturer_name": ["EDWARDS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (0485-0206-16)", "package_ndc": "0485-0206-16", "marketing_start_date": "20110307"}], "brand_name": "RYNEX PSE", "product_id": "0485-0206_4c48242c-1746-1a49-e063-6294a90ac81d", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0485-0206", "generic_name": "BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE", "labeler_name": "EDWARDS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "RYNEX PSE", "active_ingredients": [{"name": "BROMPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "15 mg/5mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20110307", "listing_expiration_date": "20271231"}