Mesalamine

Product NDC: 54092-100
Requested package NDC: 54092-100-01
11-digit product format: 540920100
Labeler code: 54092
Product ID: 54092-100_40b30d85-e11b-40a8-b15c-34a9f2efdea8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MESALAMINE
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA022000
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2017-08-29
Substance: MESALAMINE
Active strength: 1.2 g/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022000-001	LIALDA	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022000-001	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 2 · 45 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	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	N022000-001	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N022000-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022000-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022000-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022000-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022000-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022000-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022000-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022000-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022000-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022000-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022000-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022000-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022000-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022000-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022000-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022000-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022000-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022000-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022000-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022000-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022000-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022000-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022000-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022000-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022000-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022000-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022000-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022000-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022000-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022000-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022000-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022000-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022000-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022000-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022000-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022000-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022000-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022000-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022000-001	AB	1	`3bdfa0b2c4d7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022000-001	6773720	2020-06-08	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022000-001	6773720	2020-06-08	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022000-001	6773720	2020-06-08	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022000-001	6773720	2020-06-08	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022000-001	6773720	2020-06-08	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022000-001	6773720	2020-06-08	Drug product	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022000-001	NPP	2023-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022000-001	NPP	2023-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022000-001	NPP	2023-06-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022000-001	NPP	2023-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022000-001	NPP	2023-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022000-001	NPP	2023-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022000-001	NPP	2023-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022000-001	NPP	2023-06-26	`8869cabd3fbd…`
2023-12-20 04:57 UTC	2023-12	N022000-001	NPP	2023-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022000-001	NPP	2023-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022000-001	NPP	2023-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022000-001	NPP	2023-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022000-001	NPP	2023-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022000-001	NPP	2023-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022000-001	NPP	2023-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022000-001	NPP	2023-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022000-001	NPP	2023-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022000-001	NPP	2023-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022000-001	NPP	2023-06-26	`cb3db0bc1861…`

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: Mesalamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	1.2 g/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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
686429	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
4e3b6325-a5bf-4c47-931c-142c0e4d7c3a	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
54092-100-01	Mesalamine	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-100-01	EA - Each	54092-100	299ce263-d299-479c-ae4b-1a1730240a24	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54092-100	MESALAMINE TABLET, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20250112_4e3b6325-a5bf-4c47-931c-142c0e4d7c3a.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
686429	mesalamine 1.2 GM Delayed Release Oral Tablet, Once-Daily	PSN	4e3b6325-a5bf-4c47-931c-142c0e4d7c3a	10
686429	mesalamine 1200 MG Delayed Release Oral Tablet	SCD	4e3b6325-a5bf-4c47-931c-142c0e4d7c3a	10
686429	mesalazine 1.2 GM Delayed Release Oral Tablet	SY	4e3b6325-a5bf-4c47-931c-142c0e4d7c3a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-100-01	54092010001	120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-100-01)	2017-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mesalamine	Takeda Pharmaceuticals America, Inc. \| Cosmo SpA \| Sharp Packaging Services, LLC \| PharmaZell GmbH \| PharmaZell (India) Private Ltd.	2026-10-23	HUMAN PRESCRIPTION DRUG LABEL	11