Ibrance

Product NDC: 0069-0189
11-digit product format: 000690189
Labeler code: 0069
Product ID: 0069-0189_fb858b80-8bd4-43a6-8871-9819a35ca03f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: palbociclib
Dosage form: CAPSULE
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
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: 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
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.

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	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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N207103-001	M-14	2028-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N207103-001	PED	2029-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N207103-002	M-14	2028-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N207103-002	PED	2029-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N207103-003	M-14	2028-09-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N207103-003	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 · 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 ndc (product): 0069-0189

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
1601380	Internal RxNorm lookup
1601386	Internal RxNorm lookup
1601388	Internal RxNorm lookup
1601390	Internal RxNorm lookup
1601392	Internal RxNorm lookup
1601394	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
e0e6412f-50b4-4fd4-9364-62818d121a07	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
0069-0189-21	Ibrance	21 in 1 BOTTLE	CAPSULE	21		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0069-0189-21	EA - Each	0069-0189	9dd25e76-6743-4843-8da5-b3760cf11dce	1	2015-03-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0069-0189	IBRANCE (PALBOCICLIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	18	Current NDC, Legacy NDC, 1 package rows	20250507_e0e6412f-50b4-4fd4-9364-62818d121a07.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
1601386	Ibrance 100 MG Oral Capsule	PSN	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601390	Ibrance 125 MG Oral Capsule	PSN	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601394	Ibrance 75 MG Oral Capsule	PSN	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601380	palbociclib 100 MG Oral Capsule	PSN	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601388	palbociclib 125 MG Oral Capsule	PSN	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601392	palbociclib 75 MG Oral Capsule	PSN	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601386	palbociclib 100 MG Oral Capsule [Ibrance]	SBD	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601390	palbociclib 125 MG Oral Capsule [Ibrance]	SBD	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601394	palbociclib 75 MG Oral Capsule [Ibrance]	SBD	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601380	palbociclib 100 MG Oral Capsule	SCD	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601388	palbociclib 125 MG Oral Capsule	SCD	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601392	palbociclib 75 MG Oral Capsule	SCD	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601386	Ibrance 100 MG Oral Capsule	SY	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601390	Ibrance 125 MG Oral Capsule	SY	e0e6412f-50b4-4fd4-9364-62818d121a07	21
1601394	Ibrance 75 MG Oral Capsule	SY	e0e6412f-50b4-4fd4-9364-62818d121a07	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0069-0189-21	00069018921	21 CAPSULE in 1 BOTTLE (0069-0189-21)	21 capsule	2015-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibrance	Pfizer Laboratories Div Pfizer Inc \| Pharmacia & Upjohn Company LLC \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Asia Manufacturing Pte Ltd	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	24