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United States · US · US:71369-010_4d4d84be-34cd-4027-b69a-2f16ec5049ed

Doptelet Sprinkle

Orange BookUNIISPLATC B02BX08

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

Identification

ManufacturerAkaRx, Inc.
CountryUS (United States)
ATC codeB02BX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7136901030
    1 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
GDW7M2P1IS
AVATROMBOPAG MALEATE
RxCUI 2045727
Orange Book
N219696
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "GDW7M2P1IS",
    "rxcui": "2045727",
    "inchikey": "MISPBGHDNZYFNM-BTJKTKAUSA-N",
    "display_name": "AVATROMBOPAG MALEATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e2d5960d-6c18-46cc-86bd-089222b09852": {
      "match": "brand_token",
      "title": "DOPTELET (AVATROMBOPAG MALEATE) TABLET, FILM COATED DOPTELET SPRINKLE (AVATROMBOPAG) GRANULE [AKARX, INC.]",
      "spl_version": "21",
      "published_date": "2025-08-15"
    }
  },
  "productid": "71369-010_4d4d84be-34cd-4027-b69a-2f16ec5049ed",
  "productndc": "71369-010",
  "dosage_form": "GRANULE",
  "orange_book": {
    "appl_no": "219696",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jul 24, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AVATROMBOPAG MALEATE",
  "proprietary_name": "Doptelet Sprinkle",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219696",
  "marketing_category": "NDA",
  "nonproprietary_name": "avatrombopag",
  "start_marketing_date": "20250725",
  "active_numerator_strength": "10"
}

Related drugs

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