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United States · US · US:63539-486_0fdac4c6-c9e4-41de-a95b-d5bf76a93c37
Ibrance
In shortageOrange BookUNIISPLATC L01EF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerU.S. Pharmaceuticals
CountryUS (United States)
ATC codeL01EF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163539486033 DOSE PACK in 1 CARTON (63539-486-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (63539-486-07)
Annotations
UNII (FDA Substance ID)
G9ZF61LE7G
PALBOCICLIB
RxCUI 1601374
Orange Book
N212436
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Palbociclib Capsule
Raw payload (JSON)
{
"unii": {
"unii": "G9ZF61LE7G",
"rxcui": "1601374",
"inchikey": "AHJRHEGDXFFMBM-UHFFFAOYSA-N",
"display_name": "PALBOCICLIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"89a142d5-7e61-48bf-9e77-e2cd124c4792": {
"match": "brand_token",
"title": "IBRANCE (PALBOCICLIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS]",
"spl_version": "10",
"published_date": "2026-06-01"
}
},
"productid": "63539-486_0fdac4c6-c9e4-41de-a95b-d5bf76a93c37",
"productndc": "63539-486",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "212436",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "75MG",
"product_no": "001",
"approval_date": "Nov 1, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "002",
"approval_date": "Nov 1, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "125MG",
"product_no": "003",
"approval_date": "Nov 1, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PALBOCICLIB",
"shortage_reason": "Palbociclib Capsule",
"shortage_status": "current",
"proprietary_name": "Ibrance",
"active_ingred_unit": "mg/1",
"application_number": "NDA212436",
"marketing_category": "NDA",
"nonproprietary_name": "palbociclib",
"start_marketing_date": "20200330",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EF01.
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