Home NDC 63539-189 Ibrance
Product NDC 63539-189
11-digit product format 635390189
Labeler code 63539
Product ID 63539-189_fa0d4a01-f6f9-4e10-ad58-fdfd23a8ead2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name palbociclib
Dosage form CAPSULE
Route ORAL
Labeler U.S. Pharmaceuticals
Application NDA207103
Marketing category NDA
Marketing start 2015-02-03
Substance PALBOCICLIB
Active strength 125 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 N207103-001 IBRANCE PALBOCICLIB 75MG CAPSULE / ORAL RLD 2015-02-03 N207103-002 IBRANCE PALBOCICLIB 100MG CAPSULE / ORAL RLD 2015-02-03 N207103-003 IBRANCE PALBOCICLIB 125MG CAPSULE / ORAL RLD, RS 2015-02-03
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207103-001 RE47739 2027-03-05 Drug substance, Drug product 2019-12-19 N207103-001 RE47739*PED 2027-09-05 Pediatric extension N207103-001 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 N207103-001 10723730*PED 2034-08-08 Pediatric extension N207103-002 RE47739 2027-03-05 Drug substance, Drug product 2019-12-19 N207103-002 RE47739*PED 2027-09-05 Pediatric extension N207103-002 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 N207103-002 10723730*PED 2034-08-08 Pediatric extension N207103-003 RE47739 2027-03-05 Drug substance, Drug product 2019-12-19 N207103-003 RE47739*PED 2027-09-05 Pediatric extension N207103-003 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 N207103-003 10723730*PED 2034-08-08 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 N207103-001 IBRANCE 75MG CAPSULE / ORAL RLD 2015-02-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-002 IBRANCE 100MG CAPSULE / ORAL RLD 2015-02-03 a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-003 IBRANCE 125MG CAPSULE / ORAL RLD, RS 2015-02-03 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 N207103-001 RE47739 2027-03-05 Drug substance, Drug product 2019-12-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-001 RE47739*PED 2027-09-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-001 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-001 10723730*PED 2034-08-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-002 RE47739 2027-03-05 Drug substance, Drug product 2019-12-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-002 RE47739*PED 2027-09-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-002 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-002 10723730*PED 2034-08-08 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-003 RE47739 2027-03-05 Drug substance, Drug product 2019-12-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-003 RE47739*PED 2027-09-05 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-003 10723730 2034-02-08 Drug substance, Drug product 2020-08-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N207103-003 10723730*PED 2034-08-08 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibrance PALBOCICLIB Pfizer Laboratories Div Pfizer Inc e0e6412f-50b4-4fd4-9364-62818d121a07 2026-07-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 207103 application number: NDA207103
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63539-189-11 Ibrance 21 in 1 BOTTLE CAPSULE 21 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-189 IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS] 9 Current NDC, Legacy NDC, 1 package rows 20250426_86718885-da44-4d3d-b3ca-06cbcedcffd8.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63539-189-11 63539018911 21 CAPSULE in 1 BOTTLE (63539-189-11) 21 capsule 2015-02-03 0000-00-00 No No Current