Capecitabine

Product NDC: 62756-238
11-digit product format: 627560238
Labeler code: 62756
Product ID: 62756-238_8a24ef3b-b59a-4051-bf0d-a98eb6187ef2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Capecitabine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA204668
Marketing category: ANDA
Marketing start: 2019-09-01
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: 2026-12-31
Current FDA listing: Yes

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
A204668-001	CAPECITABINE	CAPECITABINE	150MG	TABLET / ORAL			2019-06-21
A204668-002	CAPECITABINE	CAPECITABINE	500MG	TABLET / ORAL			2019-06-21

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	A204668-001	CAPECITABINE	150MG	TABLET / ORAL		2019-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204668-002	CAPECITABINE	500MG	TABLET / ORAL		2019-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204668-001	CAPECITABINE	150MG	TABLET / ORAL		2019-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204668-002	CAPECITABINE	500MG	TABLET / ORAL		2019-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204668-001	CAPECITABINE	150MG	TABLET / ORAL		2019-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204668-002	CAPECITABINE	500MG	TABLET / ORAL		2019-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204668-001	CAPECITABINE	150MG	TABLET / ORAL		2019-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204668-002	CAPECITABINE	500MG	TABLET / ORAL		2019-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204668-001	CAPECITABINE	150MG	TABLET / ORAL		2019-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204668-002	CAPECITABINE	500MG	TABLET / ORAL		2019-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204668-001	CAPECITABINE	150MG	TABLET / ORAL		2019-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204668-002	CAPECITABINE	500MG	TABLET / ORAL		2019-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204668-001	CAPECITABINE	150MG	TABLET / ORAL		2019-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204668-002	CAPECITABINE	500MG	TABLET / ORAL		2019-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204668-001	CAPECITABINE	150MG	TABLET / ORAL		2019-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204668-002	CAPECITABINE	500MG	TABLET / ORAL		2019-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204668-001	CAPECITABINE	150MG	TABLET / ORAL	AB	2019-06-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204668-002	CAPECITABINE	500MG	TABLET / ORAL	AB	2019-06-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204668-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204668-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204668-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204668-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204668-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204668-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204668-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204668-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204668-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204668-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204668-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204668-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204668-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204668-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204668-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204668-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204668-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204668-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204668-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204668-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204668-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204668-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204668-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204668-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204668-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204668-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204668-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204668-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204668-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204668-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204668-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204668-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204668-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204668-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204668-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204668-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204668-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204668-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204668-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204668-002	AB	1	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Capecitabine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPECITABINE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6804DJ8Z9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200327	Internal RxNorm lookup
200328	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
e3b1a2b5-f1ce-45ea-afd8-68aac53665fa	Available on FDA.report

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	SPL version
62756-238-18	Capecitabine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	5
62756-238-86	Capecitabine	60 in 1 BOTTLE	TABLET, FILM COATED	60	5
62756-238-88	Capecitabine	100 in 1 BOTTLE	TABLET, FILM COATED	100	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-238-86	EA - Each	62756-238	1d4b4e08-fe10-4382-ad3c-5d022e2388b0	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-238	CAPECITABINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5	Current NDC, Legacy NDC, 3 package rows	20230613_e3b1a2b5-f1ce-45ea-afd8-68aac53665fa.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	Sun Pharmaceutical Industries, Inc.	e3b1a2b5-f1ce-45ea-afd8-68aac53665fa	2023-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204668 application number: ANDA204668 ndc (product): 62756-238

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	e3b1a2b5-f1ce-45ea-afd8-68aac53665fa	5
200328	capecitabine 500 MG Oral Tablet	PSN	e3b1a2b5-f1ce-45ea-afd8-68aac53665fa	5
200327	capecitabine 150 MG Oral Tablet	SCD	e3b1a2b5-f1ce-45ea-afd8-68aac53665fa	5
200328	capecitabine 500 MG Oral Tablet	SCD	e3b1a2b5-f1ce-45ea-afd8-68aac53665fa	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-238-18	62756023818	1000 TABLET, FILM COATED in 1 BOTTLE (62756-238-18)	2019-09-01	0000-00-00	No	No	Current
62756-238-86	62756023886	60 TABLET, FILM COATED in 1 BOTTLE (62756-238-86)	2019-09-01	0000-00-00	No	No	Current
62756-238-88	62756023888	100 TABLET, FILM COATED in 1 BOTTLE (62756-238-88)	2019-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Capecitabine	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2023-06-06	HUMAN PRESCRIPTION DRUG LABEL	5