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United States · US · US:65162-036_f1b3934b-1fc2-4ce8-9465-e1f031daf9c5

Guaifenesin

Orange BookUNIISPLATC R05CA03

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6516203602
    2 BLISTER PACK in 1 CARTON (65162-036-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    6516203603
    1 BOTTLE in 1 CARTON (65162-036-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • ndc11
    6516203606
    1 BOTTLE in 1 CARTON (65162-036-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
A207342
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "495W7451VQ",
    "rxcui": "5032",
    "inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
    "display_name": "GUAIFENESIN",
    "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": "65162-036_f1b3934b-1fc2-4ce8-9465-e1f031daf9c5",
  "productndc": "65162-036",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207342",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Jul 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "Jul 11, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Guaifenesin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207342",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20180727",
  "active_numerator_strength": "600"
}

Related drugs

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