Pentasa

Product NDC: 54092-191
11-digit product format: 540920191
Labeler code: 54092
Product ID: 54092-191_42661699-8fcc-40da-a05d-91906f9973e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: CAPSULE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA020049
Marketing category: NDA
Marketing start: 2004-07-08
Substance: MESALAMINE
Active strength: 500 mg/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54092-191	54092-191-08	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020049-001	PENTASA	MESALAMINE	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10
N020049-002	PENTASA	MESALAMINE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020049-001	AB
N020049-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2004-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2004-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2004-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2004-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1993-05-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2004-07-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020049-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020049-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020049-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020049-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020049-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020049-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020049-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020049-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020049-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020049-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020049-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020049-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020049-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020049-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020049-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020049-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020049-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020049-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020049-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020049-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020049-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020049-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020049-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020049-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020049-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020049-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020049-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020049-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020049-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020049-002	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Q81I59GXC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
206791	Internal RxNorm lookup
314092	Internal RxNorm lookup
476362	Internal RxNorm lookup
580286	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
e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3	Product name	3	20260128
37997c2c-8686-b078-51f1-fb15da0c0a1c	Product name	6	20260127
97851e97-0a12-4d74-aaa4-9583fe070304	Product name	2	20250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49	Product name	5	20250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564	Product name	5	20240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3	Product name	1	20230124
a4dbd90c-f616-c999-40d7-60da88952163	Product name	2	20190802
77831c26-5062-ed63-fc15-a07600377b5b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54092-191-12	Pentasa	120 in 1 BOTTLE	CAPSULE	120		42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-191-12	EA - Each	54092-191	96eca898-318e-4257-a755-3ade98be17cf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MESALAMINE	ACTIVE INGREDIENT	4Q81I59GXC	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
MESALAMINE	ACTIVE MOIETY	4Q81I59GXC	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PENTASA (MESALAMINE) CAPSULE [SHIRE US MANUFACTURING INC.]	21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54092-191	PENTASA (MESALAMINE) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]	42	Current NDC, Legacy NDC, 1 package rows	20250117_e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606.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
Pentasa	MESALAMINE	Takeda Pharmaceuticals America, Inc.	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020049 application number: NDA020049 ndc (product): 54092-191

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Q81I59GXC	MESALAMINE	89-57-6	MESALAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314092	mesalamine 250 MG Extended Release Oral Capsule	PSN	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
476362	mesalamine 500 MG Extended Release Oral Capsule	PSN	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
206791	Pentasa 250 MG Extended Release Oral Capsule	PSN	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
580286	Pentasa 500 MG Extended Release Oral Capsule	PSN	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
206791	mesalamine 250 MG Extended Release Oral Capsule [Pentasa]	SBD	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
580286	mesalamine 500 MG Extended Release Oral Capsule [Pentasa]	SBD	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
314092	mesalamine 250 MG Extended Release Oral Capsule	SCD	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
476362	mesalamine 500 MG Extended Release Oral Capsule	SCD	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
314092	mesalazine 250 MG Extended Release Oral Capsule	SY	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
206791	Pentasa 250 MG Extended Release Oral Capsule	SY	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42
580286	Pentasa 500 MG Extended Release Oral Capsule	SY	e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606	42

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-191-12	54092019112	120 CAPSULE in 1 BOTTLE (54092-191-12)	120 capsule	2004-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pentasa	Takeda Pharmaceuticals America, Inc. \| Patheon Manufacturing Services LLC \| PharmaZell GmbH \| Syntese A/S \| Sharp Packaging Services, LLC	2025-01-15	HUMAN PRESCRIPTION DRUG LABEL	42