Capecitabine

Product NDC: 42291-167
11-digit product format: 422910167
Labeler code: 42291
Product ID: 42291-167_7b0b16a0-bae8-0b95-e053-2a91aa0af913
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Capecitabine
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE, Inc.
Application: ANDA204741
Marketing category: ANDA
Marketing start: 2017-04-14
Marketing end: 0000-00-00
Substance: CAPECITABINE
Active strength: 500 mg/1
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	42291-167		D	Discontinued by firm		2026-10-15
excluded package	package	42291-167	42291-167-12	D	Discontinued by firm		2026-10-15

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-167-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-167-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-167-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-167-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-167-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-167-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-167-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-167-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-167-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-167-12	`ad56d346431e…`	`cc804d4bbf1e…`
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	42291-167-12	`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	42291-167-12	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204741-001	CAPECITABINE	CAPECITABINE	150MG	TABLET / ORAL			2017-02-28
A204741-002	CAPECITABINE	CAPECITABINE	500MG	TABLET / ORAL			2017-02-28

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 3 of 3 · 88 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
2022-10-28 04:53 UTC	2022-10	A204741-001	CAPECITABINE	150MG	TABLET / ORAL		2017-02-28	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A204741-002	CAPECITABINE	500MG	TABLET / ORAL		2017-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204741-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2017-02-28	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A204741-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2017-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204741-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2017-02-28	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204741-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2017-02-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204741-001	CAPECITABINE	150MG	TABLET / ORAL		2017-02-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204741-002	CAPECITABINE	500MG	TABLET / ORAL		2017-02-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204741-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204741-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204741-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204741-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204741-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204741-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204741-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204741-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204741-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204741-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204741-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204741-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204741-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204741-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204741-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204741-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204741-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204741-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204741-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204741-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204741-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204741-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204741-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204741-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204741-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204741-002	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A204741-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A204741-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204741-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204741-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-167-12	EA - Each	42291-167	da85c480-d36b-44ca-83a2-5ea40c85263e	1	2017-05-03