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United States · US · US:33342-189_2b583ae0-4d24-bd44-e063-6394a90a0ced

Niacin

Orange BookUNIISPLATC C10AD02

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3334218910
    90 TABLET in 1 BOTTLE (33342-189-10)
  • ndc11
    3334218911
    100 TABLET in 1 BOTTLE (33342-189-11)

Annotations

UNII (FDA Substance ID)
2679MF687A
NIACIN
RxCUI 7393
Orange Book
A204934
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2679MF687A",
    "rxcui": "7393",
    "inchikey": "PVNIIMVLHYAWGP-UHFFFAOYSA-N",
    "display_name": "NIACIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8eff9205-84ac-e69d-e053-2995a90aad4b": {
      "match": "brand_token",
      "title": "NIACIN TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "7",
      "published_date": "2026-05-11"
    }
  },
  "productid": "33342-189_2b583ae0-4d24-bd44-e063-6394a90a0ced",
  "productndc": "33342-189",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204934",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Mar 3, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Mar 3, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIACIN",
  "proprietary_name": "Niacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204934",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Niacin",
  "start_marketing_date": "20220303",
  "active_numerator_strength": "1000"
}

Related drugs

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