dextromethorphan hydrobromide and quinidine sulfate

Generic: dextromethorphan hydrobromide and quinidine sulfate

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan hydrobromide and quinidine sulfate
Generic Name dextromethorphan hydrobromide and quinidine sulfate
Labeler camber pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/1, quinidine sulfate 10 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-693
Product ID 31722-693_2d3a1851-0309-c3a1-e063-6294a90abd14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218426
Listing Expiration 2026-12-31
Marketing Start 2024-08-28

Pharmacologic Class

Classes
antiarrhythmic [epc] cytochrome p450 2d6 inhibitor [epc] cytochrome p450 2d6 inhibitors [moa] 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 31722693
Hyphenated Format 31722-693

Supplemental Identifiers

RxCUI
1040054
UNII
9D2RTI9KYH J13S2394HE

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 dextromethorphan hydrobromide and quinidine sulfate (source: ndc)
Generic Name dextromethorphan hydrobromide and quinidine sulfate (source: ndc)
Application Number ANDA218426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (31722-693-60)
source: ndc

Packages (1)

31722-693-60 60 CAPSULE in 1 BOTTLE (31722-693-60)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/1) quinidine sulfate (10 mg/1)

Linked Drug Pages (1)

Dextromethorphan hydrobromide and quinidine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d3a1851-0309-c3a1-e063-6294a90abd14", "openfda": {"unii": ["9D2RTI9KYH", "J13S2394HE"], "rxcui": ["1040054"], "spl_set_id": ["7028dcb7-f436-4cf6-9beb-23c1d215c798"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (31722-693-60)", "package_ndc": "31722-693-60", "marketing_start_date": "20240828"}], "brand_name": "Dextromethorphan hydrobromide and quinidine sulfate", "product_id": "31722-693_2d3a1851-0309-c3a1-e063-6294a90abd14", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 2D6 Inhibitor [EPC]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "31722-693", "generic_name": "Dextromethorphan hydrobromide and quinidine sulfate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dextromethorphan hydrobromide and quinidine sulfate", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "QUINIDINE SULFATE", "strength": "10 mg/1"}], "application_number": "ANDA218426", "marketing_category": "ANDA", "marketing_start_date": "20240828", "listing_expiration_date": "20261231"}