Home NDC 63539-486 Ibrance
Product NDC 63539-486
11-digit product format 635390486
Labeler code 63539
Product ID 63539-486_bdba8a62-3a62-4485-a053-e496ad7dda13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name palbociclib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler U.S. Pharmaceuticals
Application NDA212436
Marketing category NDA
Marketing start 2020-03-30
Substance PALBOCICLIB
Active strength 100 mg/1
Pharmacologic classes Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212436-001 IBRANCE PALBOCICLIB 75MG TABLET / ORAL RLD 2019-11-01 N212436-002 IBRANCE PALBOCICLIB 100MG TABLET / ORAL RLD 2019-11-01 N212436-003 IBRANCE PALBOCICLIB 125MG TABLET / ORAL RLD, RS 2019-11-01
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212436-001 RE47739 2027-03-05 Drug substance, Drug product 2019-11-26 N212436-001 RE47739*PED 2027-09-05 Pediatric extension N212436-001 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 N212436-001 10723730*PED 2034-08-08 Pediatric extension N212436-001 11065250 2036-08-19 Drug product 2021-08-12 N212436-001 11065250*PED 2037-02-19 Pediatric extension N212436-002 RE47739 2027-03-05 Drug substance, Drug product 2019-11-26 N212436-002 RE47739*PED 2027-09-05 Pediatric extension N212436-002 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 N212436-002 10723730*PED 2034-08-08 Pediatric extension N212436-002 11065250 2036-08-19 Drug product 2021-08-12 N212436-002 11065250*PED 2037-02-19 Pediatric extension N212436-003 RE47739 2027-03-05 Drug substance, Drug product 2019-11-26 N212436-003 RE47739*PED 2027-09-05 Pediatric extension N212436-003 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 N212436-003 10723730*PED 2034-08-08 Pediatric extension N212436-003 11065250 2036-08-19 Drug product 2021-08-12 N212436-003 11065250*PED 2037-02-19 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N212436-001 IBRANCE 75MG TABLET / ORAL RLD 2019-11-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-002 IBRANCE 100MG TABLET / ORAL RLD 2019-11-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-003 IBRANCE 125MG TABLET / ORAL RLD, RS 2019-11-01 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N212436-001 RE47739 2027-03-05 Drug substance, Drug product 2019-11-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-001 RE47739*PED 2027-09-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-001 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-001 10723730*PED 2034-08-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-001 11065250 2036-08-19 Drug product 2021-08-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-001 11065250*PED 2037-02-19 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-002 RE47739 2027-03-05 Drug substance, Drug product 2019-11-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-002 RE47739*PED 2027-09-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-002 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-002 10723730*PED 2034-08-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-002 11065250 2036-08-19 Drug product 2021-08-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-002 11065250*PED 2037-02-19 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-003 RE47739 2027-03-05 Drug substance, Drug product 2019-11-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-003 RE47739*PED 2027-09-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-003 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-003 10723730*PED 2034-08-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-003 11065250 2036-08-19 Drug product 2021-08-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N212436-003 11065250*PED 2037-02-19 Pediatric extension a50c72e98297…
Observed Orange Book exclusivity history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Ibrance
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PALBOCICLIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G9ZF61LE7G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2284102 Internal RxNorm lookup 2284104 Internal RxNorm lookup 2284105 Internal RxNorm lookup 2284106 Internal RxNorm lookup 2284107 Internal RxNorm lookup 2284108 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63539-486-03 Ibrance 3 in 1 CARTON TABLET, FILM COATED 3 9 63539-486-07 Ibrance 7 in 1 DOSE PACK TABLET, FILM COATED 7 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-486 IBRANCE (PALBOCICLIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 7 Current NDC, Legacy NDC, 2 package rows 20250426_89a142d5-7e61-48bf-9e77-e2cd124c4792.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63539-486-03 63539048603 3 DOSE PACK in 1 CARTON (63539-486-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (63539-486-07) 3 dose pack 2020-03-30 0000-00-00 No No Current 63539-486-07 63539048607 7 in 1 DOSE PACK Historical