Guaifenesin and Dextromethorphan HBr

Orange BookUNIISPLATC R05DA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSUN PHARMACEUTICAL INDUSTRIES, INC.

CountryUS (United States)

ATC codeR05DA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6330411054
1 BLISTER PACK in 1 CARTON (63304-110-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

9D2RTI9KYH

DEXTROMETHORPHAN HYDROBROMIDE

RxCUI 102490

Orange Book

A214781

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
      "match": "brand_token",
      "title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
      "spl_version": "8",
      "published_date": "2026-05-21"
    }
  },
  "productid": "63304-110_801949ca-1baf-4a19-8466-91b4269a2c63",
  "productndc": "63304-110",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "214781",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG;600MG",
        "product_no": "001",
        "approval_date": "Jul 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG;1.2GM",
        "product_no": "002",
        "approval_date": "Jul 1, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "Guaifenesin and Dextromethorphan HBr",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA214781",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin and Dextromethorphan HBr",
  "start_marketing_date": "20210701",
  "active_numerator_strength": "60; 1200"
}

Related drugs

Other records sharing ATC code R05DA.

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