Pentasa

Product NDC: 54092-189
Requested package NDC: 54092-189-81
11-digit product format: 540920189
Labeler code: 54092
Product ID: 54092-189_d98da9dd-6bcf-469c-bf7c-080565f146ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: CAPSULE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA020049
Marketing category: NDA
Marketing start: 1993-05-10
Substance: MESALAMINE
Active strength: 250 mg/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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 · 90 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
2026-11-14 07:37:17	2026-10	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020049-001	PENTASA	250MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1993-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020049-002	PENTASA	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2004-07-08	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	N020049-001	AB	1	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N020049-002	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N020049-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020049-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020049-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020049-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020049-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020049-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Pentasa
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	250 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
54092-189-81	Pentasa	240 in 1 BOTTLE	CAPSULE	240		42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-189-81	EA - Each	54092-189	e34db734-d988-4254-9773-bff80d3fa59a	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
MESALAMINE	ACTIVE INGREDIENT	4Q81I59GXC	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MESALAMINE	ACTIVE MOIETY	4Q81I59GXC	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PENTASA (MESALAMINE) CAPSULE [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54092-189	PENTASA (MESALAMINE) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]	42	Current NDC, Legacy NDC, 1 package rows	20250117_e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606.zip

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
314092	mesalamine 250 MG Extended Release Oral Capsule	PSN	ec53b1d4-b98d-4b4d-acc3-199f98031966	3
206791	Pentasa 250 MG Extended Release Oral Capsule	PSN	ec53b1d4-b98d-4b4d-acc3-199f98031966	3
206791	mesalamine 250 MG Extended Release Oral Capsule [Pentasa]	SBD	ec53b1d4-b98d-4b4d-acc3-199f98031966	3
314092	mesalamine 250 MG Extended Release Oral Capsule	SCD	ec53b1d4-b98d-4b4d-acc3-199f98031966	3
314092	mesalazine 250 MG Extended Release Oral Capsule	SY	ec53b1d4-b98d-4b4d-acc3-199f98031966	3
206791	Pentasa 250 MG Extended Release Oral Capsule	SY	ec53b1d4-b98d-4b4d-acc3-199f98031966	3
314092	mesalamine 250 MG Extended Release Oral Capsule	PSN	3a4dbb01-3c0f-4217-8e33-e37263878828	1
206791	Pentasa 250 MG Extended Release Oral Capsule	PSN	3a4dbb01-3c0f-4217-8e33-e37263878828	1
206791	mesalamine 250 MG Extended Release Oral Capsule [Pentasa]	SBD	3a4dbb01-3c0f-4217-8e33-e37263878828	1
314092	mesalamine 250 MG Extended Release Oral Capsule	SCD	3a4dbb01-3c0f-4217-8e33-e37263878828	1
314092	mesalazine 250 MG Extended Release Oral Capsule	SY	3a4dbb01-3c0f-4217-8e33-e37263878828	1
206791	Pentasa 250 MG Extended Release Oral Capsule	SY	3a4dbb01-3c0f-4217-8e33-e37263878828	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-189-81	54092018981	240 CAPSULE in 1 BOTTLE (54092-189-81)	240 capsule	1993-05-10	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	2026-10-23	HUMAN PRESCRIPTION DRUG LABEL	43
Pentasa	Carilion Materials Management	2016-08-06	HUMAN PRESCRIPTION DRUG LABEL	3
Pentasa	Avera McKennan Hospital	2016-01-05	HUMAN PRESCRIPTION DRUG LABEL	1