Ibrance

In shortageOrange BookUNIISPLATC L01EF01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc

CountryUS (United States)

ATC codeL01EF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0069048603
3 DOSE PACK in 1 CARTON (0069-0486-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0486-07)

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": "0069-0486_01800bda-3788-40c5-976b-c054dda1c0b2",
  "productndc": "0069-0486",
  "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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