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United States · US · US:71369-020_4d4d84be-34cd-4027-b69a-2f16ec5049ed
DOPTELET
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 · 3
- ndc1171369020101 BLISTER PACK in 1 CARTON (71369-020-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11)
- ndc1171369020151 BLISTER PACK in 1 CARTON (71369-020-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16)
- ndc1171369020302 BLISTER PACK in 1 CARTON (71369-020-30) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16)
Annotations
UNII (FDA Substance ID)
GDW7M2P1IS
AVATROMBOPAG MALEATE
RxCUI 2045727
Orange Book
N210238
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": "71369-020_4d4d84be-34cd-4027-b69a-2f16ec5049ed",
"productndc": "71369-020",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210238",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "May 21, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AVATROMBOPAG MALEATE",
"proprietary_name": "DOPTELET",
"active_ingred_unit": "mg/1",
"application_number": "NDA210238",
"marketing_category": "NDA",
"nonproprietary_name": "avatrombopag maleate",
"start_marketing_date": "20180523",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code B02BX08.
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