Ibrance

Product NDC: 63539-188
Requested package NDC: 63539-188-11
11-digit product format: 635390188
Labeler code: 63539
Product ID: 63539-188_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: 2017-05-08
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63539-188	63539-188-11	D	Discontinued by firm		2026-08-11

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	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	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207103-001	M-14	2028-09-16
N207103-001	PED	2029-03-16
N207103-002	M-14	2028-09-16
N207103-002	PED	2029-03-16
N207103-003	M-14	2028-09-16
N207103-003	PED	2029-03-16

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207103-002	IBRANCE	100MG	CAPSULE / ORAL	RLD	2015-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207103-003	IBRANCE	125MG	CAPSULE / ORAL	RLD, RS	2015-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207103-001	IBRANCE	75MG	CAPSULE / ORAL	RLD	2015-02-03	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 549 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-001	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-001	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	RE47739*PED	2027-09-05	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	10723730*PED	2034-08-08	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	RE47739*PED	2027-09-05	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	10723730*PED	2034-08-08	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207103-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-003	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207103-003	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-001	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-001	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-002	RE47739	2027-03-05	Drug substance, Drug product	2019-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207103-002	10723730	2034-02-08	Drug substance, Drug product	2020-08-27	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207103-001	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-001	PED	2029-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-002	PED	2029-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	M-14	2028-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207103-003	PED	2029-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-001	PED	2029-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-002	PED	2029-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	M-14	2028-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207103-003	PED	2029-03-16	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	N207103-001	I-725	2019-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-001	NCE	2020-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-002	I-725	2019-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-002	NCE	2020-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-003	I-725	2019-02-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207103-003	NCE	2020-02-03	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N207103-001	NCE	2020-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207103-002	NCE	2020-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207103-003	NCE	2020-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207103-001	NCE	2020-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207103-002	NCE	2020-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207103-003	NCE	2020-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207103-001	I-725	2019-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-001	NCE	2020-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-002	I-725	2019-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-002	NCE	2020-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-003	I-725	2019-02-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207103-003	NCE	2020-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207103-001	I-725	2019-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-001	NCE	2020-02-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-002	I-725	2019-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-002	NCE	2020-02-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-003	I-725	2019-02-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207103-003	NCE	2020-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207103-001	I-725	2019-02-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207103-001	NCE	2020-02-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207103-002	I-725	2019-02-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207103-002	NCE	2020-02-03	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c1f85e95-ece0-4b26-a786-e9ff64eb69dc	Product name	1	20200415
5a4db755-de93-485c-89bf-cac499b46d8c	Product name	2	20160328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63539-188-11	Ibrance	21 in 1 BOTTLE	CAPSULE	21		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PALBOCICLIB	ACTIVE INGREDIENT	G9ZF61LE7G	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
PALBOCICLIB	ACTIVE MOIETY	G9ZF61LE7G	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63539-188	IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 1 package rows	20250426_86718885-da44-4d3d-b3ca-06cbcedcffd8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G9ZF61LE7G	PALBOCICLIB	571190-30-2	PALBOCICLIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63539-188-11	63539018811	21 CAPSULE in 1 BOTTLE (63539-188-11)	21 capsule	2017-05-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibrance	U.S. Pharmaceuticals \| Pharmacia & Upjohn Company LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	11