Selexipag TITRATION PACK

Orange BookSPL

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071016537
1 KIT in 1 CARTON (70710-1653-7) * 1 BOTTLE in 1 CARTON / 140 TABLET, FILM COATED in 1 BOTTLE (70710-1551-8) * 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE (70710-1554-6)

Annotations

Orange Book

A214302

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "70710-1653_96a3e445-2cb7-4fb5-b95b-3f71f5f72504",
  "productndc": "70710-1653",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Selexipag TITRATION PACK",
  "active_ingred_unit": null,
  "application_number": "ANDA214302",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Selexipag",
  "start_marketing_date": "20250214",
  "active_numerator_strength": null
}

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