Pentasa

Product NDC: 69189-0189
11-digit product format: 691890189
Labeler code: 69189
Product ID: 69189-0189_6618dfe2-5b3c-4357-a0bf-b58901cd367b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: CAPSULE
Route: ORAL
Labeler: Avera McKennan Hospital
Application: NDA020049
Marketing category: NDA
Marketing start: 2015-04-27
Marketing end: 0000-00-00
Substance: MESALAMINE
Active strength: 250 mg/1
Pharmacologic classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	69189-0189		I	Inactivated by FDA		2026-08-11
excluded package	package	69189-0189	69189-0189-1	I	Inactivated by FDA		2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69189-0189-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69189-0189-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69189-0189-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69189-0189-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69189-0189-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69189-0189-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69189-0189-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69189-0189-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69189-0189-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69189-0189-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69189-0189-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69189-0189-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69189-0189-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69189-0189-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69189-0189-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69189-0189-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69189-0189-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69189-0189-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69189-0189-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69189-0189-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69189-0189-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69189-0189-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69189-0189-1	2020-01-31	C162847	48780-1	9d75b9d1-260a-f424-e053-dadaa90a57ce	PENTASA ® (mesalamine) Controlled-Release Capsules 250 mg Prescribing Information as of 10/2015 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69189-0189-1	Pentasa	1 in 1 DOSE PACK	CAPSULE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69189-0189	PENTASA (MESALAMINE) CAPSULE [AVERA MCKENNAN HOSPITAL]	1	Legacy NDC, 1 package rows	20160302_3a4dbb01-3c0f-4217-8e33-e37263878828.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

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	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	Status
69189-0189-1	69189018901	1 in 1 DOSE PACK	Historical