promethazine hydrochloride and dextromethorphan hydrobromide (65162-680)

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and dextromethorphan hydrobromide

Generic Name promethazine hydrochloride and dextromethorphan hydrobromide

Labeler amneal pharmaceuticals llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

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

Manufacturer

Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-680

Product ID 65162-680_5897cff8-507a-42b0-bcf2-4712589704df

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090575

Listing Expiration 2026-12-31

Marketing Start 2011-03-04

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 65162680

Hyphenated Format 65162-680

Supplemental Identifiers

RxCUI

991528

UNII

9D2RTI9KYH R61ZEH7I1I

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 promethazine hydrochloride and dextromethorphan hydrobromide (source: ndc)

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

Application Number ANDA090575 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

15 mg/5mL
6.25 mg/5mL

source: ndc

Packaging

118 mL in 1 BOTTLE (65162-680-86)
473 mL in 1 BOTTLE (65162-680-90)

source: ndc

Packages (2)

65162-680-86 118 mL in 1 BOTTLE (65162-680-86) 65162-680-90 473 mL in 1 BOTTLE (65162-680-90)

Ingredients (2)

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

Linked Drug Pages (1)

Promethazine Hydrochloride and Dextromethorphan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "5897cff8-507a-42b0-bcf2-4712589704df", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["6081c216-0bed-40f0-8732-f999647003d5"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (65162-680-86)", "package_ndc": "65162-680-86", "marketing_start_date": "20110304"}, {"sample": false, "description": "473 mL in 1 BOTTLE (65162-680-90)", "package_ndc": "65162-680-90", "marketing_start_date": "20110304"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "product_id": "65162-680_5897cff8-507a-42b0-bcf2-4712589704df", "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": "65162-680", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA090575", "marketing_category": "ANDA", "marketing_start_date": "20110304", "listing_expiration_date": "20261231"}