Ibrance

Product NDC: 0069-0688
11-digit product format: 000690688
Labeler code: 0069
Product ID: 0069-0688_01800bda-3788-40c5-976b-c054dda1c0b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: palbociclib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA212436
Marketing category: NDA
Marketing start: 2020-03-30
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: 2027-12-31
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	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	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212436-001	M-14	2028-09-16
N212436-001	PED	2029-03-16
N212436-002	M-14	2028-09-16
N212436-002	PED	2029-03-16
N212436-003	M-14	2028-09-16
N212436-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N212436-001	M-14	2028-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212436-001	PED	2029-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212436-002	M-14	2028-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212436-002	PED	2029-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212436-003	M-14	2028-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N212436-003	PED	2029-03-16	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibrance	PALBOCICLIB	U.S. Pharmaceuticals	89a142d5-7e61-48bf-9e77-e2cd124c4792	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212436 application number: NDA212436
Ibrance	PALBOCICLIB	Pfizer Laboratories Div Pfizer Inc	fecbdd7d-b729-41b5-9872-231b8fe104ce	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212436 application number: NDA212436 ndc (product): 0069-0688

Additional Listing Data#

Finished product: Yes
Brand name base: Ibrance
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALBOCICLIB	125 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fecbdd7d-b729-41b5-9872-231b8fe104ce	Available on FDA.report

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
0069-0688-03	Ibrance	3 in 1 CARTON	TABLET, FILM COATED	3		12
0069-0688-07	Ibrance	7 in 1 DOSE PACK	TABLET, FILM COATED	7		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-0688-03	EA - Each	0069-0688	1e9a144d-05c6-4948-9b34-515a8e401453	1	2020-04-20
0069-0688-07	EA - Each	0069-0688	596b2b22-4d47-45ef-abb0-35ad9e3afd16	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-0688	IBRANCE (PALBOCICLIB) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]	10	Current NDC, Legacy NDC, 2 package rows	20250507_fecbdd7d-b729-41b5-9872-231b8fe104ce.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2284104	Ibrance 100 MG Oral Tablet	PSN	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284106	Ibrance 125 MG Oral Tablet	PSN	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284108	Ibrance 75 MG Oral Tablet	PSN	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284102	palbociclib 100 MG Oral Tablet	PSN	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284105	palbociclib 125 MG Oral Tablet	PSN	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284107	palbociclib 75 MG Oral Tablet	PSN	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284104	palbociclib 100 MG Oral Tablet [Ibrance]	SBD	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284106	palbociclib 125 MG Oral Tablet [Ibrance]	SBD	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284108	palbociclib 75 MG Oral Tablet [Ibrance]	SBD	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284102	palbociclib 100 MG Oral Tablet	SCD	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284105	palbociclib 125 MG Oral Tablet	SCD	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284107	palbociclib 75 MG Oral Tablet	SCD	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284104	Ibrance 100 MG Oral Tablet	SY	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284106	Ibrance 125 MG Oral Tablet	SY	fecbdd7d-b729-41b5-9872-231b8fe104ce	12
2284108	Ibrance 75 MG Oral Tablet	SY	fecbdd7d-b729-41b5-9872-231b8fe104ce	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-0688-03	00069068803	3 DOSE PACK in 1 CARTON (0069-0688-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0688-07)	3 dose pack	2020-03-30	0000-00-00	No	No	Current
0069-0688-07	00069068807	7 in 1 DOSE PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibrance	Pfizer Laboratories Div Pfizer Inc \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	13