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United States · US · US:50991-999_472e3862-eab9-2279-e063-6394a90adb4c

Norgesic Forte

Orange BookUNIISPLATC A01AD

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

Identification

ManufacturerPoly Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5099199960
    60 TABLET, MULTILAYER in 1 BOTTLE (50991-999-60)

Annotations

UNII (FDA Substance ID)
R16CO5Y76E
ASPIRIN
RxCUI 1191
Orange Book
A075141
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R16CO5Y76E",
    "rxcui": "1191",
    "inchikey": "BSYNRYMUTXBXSQ-UHFFFAOYSA-N",
    "display_name": "ASPIRIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "be2761bc-e537-4039-846a-2ffa3d8b2afc": {
      "match": "brand_token",
      "title": "NORGESIC (ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE) TABLET [GALT PHARMACEUTICALS, LLC]",
      "spl_version": "3",
      "published_date": "2026-01-12"
    }
  },
  "productid": "50991-999_472e3862-eab9-2279-e063-6394a90adb4c",
  "productndc": "50991-999",
  "dosage_form": "TABLET, MULTILAYER",
  "orange_book": {
    "appl_no": "075141",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "385MG;30MG;25MG",
        "product_no": "001",
        "approval_date": "May 29, 1998"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "770MG;60MG;50MG",
        "product_no": "002",
        "approval_date": "May 29, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE",
  "proprietary_name": "Norgesic Forte",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA075141",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Orphenadrine Citrate, Aspirin and Caffeine",
  "start_marketing_date": "20190401",
  "active_numerator_strength": "770; 60; 50"
}

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