Capecitabine

Product NDC: 59923-721
11-digit product format: 599230721
Labeler code: 59923
Product ID: 59923-721_b8e44f52-4f4f-e904-e053-2a95a90a1438
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Capecitabine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Areva Pharmaceuticals
Application: ANDA207456
Marketing category: ANDA
Marketing start: 2020-03-01
Marketing end: 0000-00-00
Substance: CAPECITABINE
Active strength: 150 mg/1
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59923-721		I	Inactivated by FDA		2026-08-17
excluded package	package	59923-721	59923-721-60	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59923-721-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59923-721-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59923-721-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59923-721-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59923-721-60	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207456-001	CAPECITABINE	CAPECITABINE	150MG	TABLET / ORAL	AB		2016-12-12
A207456-002	CAPECITABINE	CAPECITABINE	500MG	TABLET / ORAL	AB		2016-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207456-001	AB
A207456-002	AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207456-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2016-12-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207456-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2016-12-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207456-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207456-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207456-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207456-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207456-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207456-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207456-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207456-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207456-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207456-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207456-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207456-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207456-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207456-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207456-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207456-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207456-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207456-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207456-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207456-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207456-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207456-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207456-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207456-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207456-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207456-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207456-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207456-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207456-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207456-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207456-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207456-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207456-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207456-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207456-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207456-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207456-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207456-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207456-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207456-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a5eae620-c3a7-41bb-55a8-fce9c3eb9864	Product name	9	20180820

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59923-721-60	2024-11-04	C162847	48780-1	1030e365-08b6-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CAPECITABINE TABLETS safely and effectively. See full prescribing information for CAPECITABINE TABLETS. CAPECITABINE tablets, for oral use Initial U.S. Approval: 1998
59923-721-60	2024-01-30	C162847	48780-1	1030e365-08b6-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CAPECITABINE TABLETS safely and effectively. See full prescribing information for CAPECITABINE TABLETS. CAPECITABINE tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59923-721-60	Capecitabine	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59923-721-60	EA - Each	59923-721	9f19eaa8-be96-4714-8d26-a4cebaed0d19	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59923-721	CAPECITABINE TABLET, FILM COATED [AREVA PHARMACEUTICALS]	3	Legacy NDC, 1 package rows	20241105_9ec7f840-e746-ded8-e053-2995a90ab3a2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Capecitabine 500mg	CAPECITABINE	Armas Pharmaceuticals Inc.	f050d16c-ab76-489d-b92c-8c155b4e3f7c	2020-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207456 application number: ANDA207456
Capecitabine 150mg	CAPECITABINE	Armas Pharmaceuticals Inc.	7f555b6b-60db-45e2-a61e-537e57f43fdc	2020-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207456 application number: ANDA207456

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6804DJ8Z9U	CAPECITABINE	154361-50-9	CAPECITABINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200327	capecitabine 150 MG Oral Tablet	PSN	9ec7f840-e746-ded8-e053-2995a90ab3a2	3
200328	capecitabine 500 MG Oral Tablet	PSN	9ec7f840-e746-ded8-e053-2995a90ab3a2	3
200327	capecitabine 150 MG Oral Tablet	SCD	9ec7f840-e746-ded8-e053-2995a90ab3a2	3
200328	capecitabine 500 MG Oral Tablet	SCD	9ec7f840-e746-ded8-e053-2995a90ab3a2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59923-721-60	59923072160	60 TABLET, FILM COATED in 1 BOTTLE (59923-721-60)	2020-03-01	0000-00-00	No	No	Current