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United States · US · US:57483-280_77d8fc95-d94b-42f5-97ae-b5ff59ef638b

Crcle Guaifensin Extended Release Tablet, 1200 mg

Orange BookUNIIATC R05CA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerInnovus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5748328002
    4 BLISTER PACK in 1 CARTON (57483-280-02) / 14 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A213420
Raw payload (JSON)
{
  "unii": {
    "unii": "495W7451VQ",
    "rxcui": "5032",
    "inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
    "display_name": "GUAIFENESIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "57483-280_77d8fc95-d94b-42f5-97ae-b5ff59ef638b",
  "productndc": "57483-280",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213420",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Crcle Guaifensin Extended Release Tablet, 1200 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213420",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifensin Extended-Release",
  "start_marketing_date": "20200910",
  "active_numerator_strength": "1200"
}

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