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United States · US · US:59651-018_8539231f-47da-402e-b05d-16c45cc3670c

Niacin

Orange BookUNIISPLATC C10AD02

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

Identification

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

Packs · 3

  • ndc11
    5965101805
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-05)
  • ndc11
    5965101818
    180 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-18)
  • ndc11
    5965101890
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-018-90)

Annotations

UNII (FDA Substance ID)
2679MF687A
NIACIN
RxCUI 7393
Orange Book
A209236
ABABAB
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": "59651-018_8539231f-47da-402e-b05d-16c45cc3670c",
  "productndc": "59651-018",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209236",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Feb 1, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Feb 1, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Feb 1, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIACIN",
  "proprietary_name": "Niacin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209236",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Niacin",
  "start_marketing_date": "20180201",
  "active_numerator_strength": "500"
}

Related drugs

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