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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
- ndc1171369010301 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
Other records sharing ATC code B02BX08.
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