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United States · US · US:0037-6860_9a4c3abc-74c9-4a2c-a8e3-fc0100d873d9

Dipentum

Orange BookUNIISPLATC A07EC03

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

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeA07EC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0037686010
    100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)

Annotations

UNII (FDA Substance ID)
Y7JEW0XG7I
OLSALAZINE SODIUM
RxCUI 104123
Orange Book
N019715
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Y7JEW0XG7I",
    "rxcui": "104123",
    "inchikey": "ZJEFYLVGGFISGT-VRZXRVJBSA-L",
    "display_name": "OLSALAZINE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8512d0c6-db4e-4673-b3b4-28975c18413f": {
      "match": "brand_token",
      "title": "DIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [VIATRIS SPECIALTY LLC]",
      "spl_version": "15",
      "published_date": "2025-08-25"
    }
  },
  "productid": "0037-6860_9a4c3abc-74c9-4a2c-a8e3-fc0100d873d9",
  "productndc": "0037-6860",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "019715",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 31, 1990"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLSALAZINE SODIUM",
  "proprietary_name": "Dipentum",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019715",
  "marketing_category": "NDA",
  "nonproprietary_name": "olsalazine sodium",
  "start_marketing_date": "20150515",
  "active_numerator_strength": "250"
}

Related drugs

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