Selexipag

Orange BookUNIISPLATC B01AC27

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeB01AC27

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071015536
60 TABLET, FILM COATED in 1 BOTTLE (70710-1553-6)

Annotations

UNII (FDA Substance ID)

5EXC0E384L

SELEXIPAG

RxCUI 1729002

Orange Book

A214302

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5EXC0E384L",
    "rxcui": "1729002",
    "inchikey": "QXWZQTURMXZVHJ-UHFFFAOYSA-N",
    "display_name": "SELEXIPAG",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ff660787-880f-4f2b-baac-fd2dbfcd79c2": {
      "match": "brand_token",
      "title": "SELEXIPAG TABLET, FILM COATED SELEXIPAG TITRATION PACK (SELEXIPAG) KIT [ZYDUS LIFESCIENCES LIMITED]",
      "spl_version": "2",
      "published_date": "2025-12-09"
    }
  },
  "productid": "70710-1553_96a3e445-2cb7-4fb5-b95b-3f71f5f72504",
  "productndc": "70710-1553",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214302",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.2MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.4MG",
        "product_no": "002",
        "approval_date": "Dec 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.6MG",
        "product_no": "003",
        "approval_date": "Dec 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.8MG",
        "product_no": "004",
        "approval_date": "Dec 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG",
        "product_no": "005",
        "approval_date": "Dec 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.2MG",
        "product_no": "006",
        "approval_date": "Dec 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.4MG",
        "product_no": "007",
        "approval_date": "Dec 21, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.6MG",
        "product_no": "008",
        "approval_date": "Dec 21, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SELEXIPAG",
  "proprietary_name": "Selexipag",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA214302",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Selexipag",
  "start_marketing_date": "20250214",
  "active_numerator_strength": "600"
}

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