🇺🇸
United States · US · US:72865-301_3bc65bc5-9a03-0ece-e063-6394a90a0a7c
ELTROMBOPAG
Orange BookUNIISPLATC B02BX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXLCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeB02BX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11728653011414 TABLET, FILM COATED in 1 BOTTLE (72865-301-14)
- ndc11728653013030 TABLET, FILM COATED in 1 BOTTLE (72865-301-30)
Annotations
UNII (FDA Substance ID)
4U07F515LG
ELTROMBOPAG OLAMINE
RxCUI 735651
Orange Book
A206788
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4U07F515LG",
"rxcui": "735651",
"inchikey": "PLILLUUXAVKBPY-SBIAVEDLSA-N",
"display_name": "ELTROMBOPAG OLAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4af8f855-f710-e96f-e063-6294a90abb46": {
"match": "brand_token",
"title": "ELTROMBOPAG OLAMINE (ELTROMBOPAG) TABLET, FILM COATED [AVKARE]",
"spl_version": "2",
"published_date": "2026-05-22"
}
},
"productid": "72865-301_3bc65bc5-9a03-0ece-e063-6394a90a0a7c",
"productndc": "72865-301",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "206788",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 12.5MG ACID",
"product_no": "001",
"approval_date": "Jan 17, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG ACID",
"product_no": "002",
"approval_date": "Jan 17, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG ACID",
"product_no": "003",
"approval_date": "Jan 17, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG ACID",
"product_no": "004",
"approval_date": "Jan 17, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ELTROMBOPAG OLAMINE",
"proprietary_name": "ELTROMBOPAG",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206788",
"marketing_category": "ANDA",
"nonproprietary_name": "ELTROMBOPAG",
"start_marketing_date": "20250807",
"active_numerator_strength": "50"
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