promethazine hydrochloride and dextromethorphan hydrobromide oral (50090-6585)

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and dextromethorphan hydrobromide oral

Generic Name promethazine hydrochloride and dextromethorphan hydrobromide oral

Labeler a-s medication solutions

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 15 mg/5mL, promethazine hydrochloride 6.25 mg/5mL

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6585

Product ID 50090-6585_146ea904-9204-4638-bcd3-b42aebee0845

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040649

Listing Expiration 2026-12-31

Marketing Start 2020-10-05

Pharmacologic Class

Classes

phenothiazine [epc] phenothiazines [cs] 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 500906585

Hyphenated Format 50090-6585

Supplemental Identifiers

RxCUI

991528

UNII

9D2RTI9KYH R61ZEH7I1I

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 promethazine hydrochloride and dextromethorphan hydrobromide oral (source: ndc)

Generic Name promethazine hydrochloride and dextromethorphan hydrobromide oral (source: ndc)

Application Number ANDA040649 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

15 mg/5mL
6.25 mg/5mL

source: ndc

Packaging

118 mL in 1 BOTTLE (50090-6585-0)

source: ndc

Packages (1)

50090-6585-0 118 mL in 1 BOTTLE (50090-6585-0)

Ingredients (2)

dextromethorphan hydrobromide (15 mg/5mL) promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "146ea904-9204-4638-bcd3-b42aebee0845", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["9c3e0e87-b2f5-4a09-9db8-6d088d2a5f25"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (50090-6585-0)", "package_ndc": "50090-6585-0", "marketing_start_date": "20230809"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral", "product_id": "50090-6585_146ea904-9204-4638-bcd3-b42aebee0845", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "50090-6585", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040649", "marketing_category": "ANDA", "marketing_start_date": "20201005", "listing_expiration_date": "20261231"}