CAPECITABINE

Product NDC: 68001-488
11-digit product format: 680010488
Labeler code: 68001
Product ID: 68001-488_cc96ef8c-c7a2-64fc-e053-2a95a90aabe5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CAPECITABINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA202593
Marketing category: ANDA
Marketing start: 2021-02-22
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: 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	68001-488		D	Discontinued by firm		2026-10-15
excluded package	package	68001-488	68001-488-07	D	Discontinued by firm		2026-10-15

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
A202593-001	CAPECITABINE	CAPECITABINE	150MG	TABLET / ORAL	AB		2015-04-23
A202593-002	CAPECITABINE	CAPECITABINE	500MG	TABLET / ORAL	AB		2015-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202593-001	AB
A202593-002	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 · 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
2026-10-15 13:18:30	2026-09	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202593-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2015-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202593-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2015-04-23	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202593-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202593-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202593-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202593-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202593-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202593-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202593-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202593-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202593-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202593-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202593-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202593-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202593-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202593-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202593-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202593-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202593-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202593-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202593-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202593-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202593-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202593-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202593-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202593-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202593-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202593-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202593-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202593-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202593-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202593-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202593-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202593-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202593-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202593-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202593-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202593-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202593-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202593-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202593-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202593-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-488-07	CAPECITABINE	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	120		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-488-07	EA - Each	68001-488	f78185a0-bc42-44a1-a91d-6db56ea8464c	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-488	CAPECITABINE TABLET, FILM COATED [BLUEPOINT LABORATORIES]	3	Legacy NDC, 1 package rows	20230601_bbb12406-ce02-3f31-e053-2995a90a0b16.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
CAPECITABINE	CAPECITABINE	Accord Healthcare Inc.	8345d55e-ad02-4726-a04b-1a46e3337a4b	2024-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202593 application number: ANDA202593

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	bbb12406-ce02-3f31-e053-2995a90a0b16	3
200328	capecitabine 500 MG Oral Tablet	PSN	bbb12406-ce02-3f31-e053-2995a90a0b16	3
200327	capecitabine 150 MG Oral Tablet	SCD	bbb12406-ce02-3f31-e053-2995a90a0b16	3
200328	capecitabine 500 MG Oral Tablet	SCD	bbb12406-ce02-3f31-e053-2995a90a0b16	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-488-07	68001048807	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-488-07)	2021-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CAPECITABINE	BluePoint Laboratories \| Intas Pharmaceuticals Ltd	2023-05-31	HUMAN PRESCRIPTION DRUG LABEL	3