Lialda

Product NDC: 54092-476
11-digit product format: 540920476
Labeler code: 54092
Product ID: 54092-476_405a190f-df13-4578-a988-5b291b284f21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA022000
Marketing category: NDA
Marketing start: 2007-01-16
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 1.

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 · 41 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	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…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022000-001	LIALDA	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-01-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022000-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022000-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022000-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022000-001	AB	1	`cb3db0bc1861…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lialda
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
686429	Internal RxNorm lookup
686433	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
3098a080-be86-4265-9818-7fc4beab77b7	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	SPL version
54092-476-01	Lialda	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	49
54092-476-02	Lialda	12 in 1 CARTON	TABLET, DELAYED RELEASE	12	49
54092-476-08	Lialda	3 in 1 CARTON	TABLET, DELAYED RELEASE	3	49
54092-476-08	Lialda	8 in 1 CARTON	TABLET, DELAYED RELEASE	8	49
54092-476-12	Lialda	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-476-01	EA - Each	54092-476	123aaa47-c820-4ade-916f-2609eb968b4b	1	2019-07-02
54092-476-02	EA - Each	54092-476	7e8ae41d-e638-4076-acc1-0152c76d0178	1	2014-11-05
54092-476-12	EA - Each	54092-476	671127db-f58f-41b9-97ce-cd7e0db7bca0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MESALAMINE	ACTIVE INGREDIENT	4Q81I59GXC	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
MESALAMINE	ACTIVE MOIETY	4Q81I59GXC	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [SHIRE US MANUFACTURING INC.]	26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54092-476	LIALDA (MESALAMINE) TABLET, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]	46	Current NDC, Legacy NDC, 5 package rows	20231104_3098a080-be86-4265-9818-7fc4beab77b7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lialda	MESALAMINE	Takeda Pharmaceuticals America, Inc.	3098a080-be86-4265-9818-7fc4beab77b7	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022000 application number: NDA022000 ndc (product): 54092-476
Mesalamine	MESALAMINE	Takeda Pharmaceuticals America, Inc.	4e3b6325-a5bf-4c47-931c-142c0e4d7c3a	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022000 application number: NDA022000

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
686433	Lialda 1. 2 GM Delayed Release Oral Tablet, Once-Daily	PSN	3098a080-be86-4265-9818-7fc4beab77b7	49
686429	mesalamine 1.2 GM Delayed Release Oral Tablet, Once-Daily	PSN	3098a080-be86-4265-9818-7fc4beab77b7	49
686433	mesalamine 1200 MG Delayed Release Oral Tablet [Lialda]	SBD	3098a080-be86-4265-9818-7fc4beab77b7	49
686429	mesalamine 1200 MG Delayed Release Oral Tablet	SCD	3098a080-be86-4265-9818-7fc4beab77b7	49
686433	Lialda 1.2 GM Delayed Release Oral Tablet	SY	3098a080-be86-4265-9818-7fc4beab77b7	49
686433	Lialda 1200 MG Delayed Release Oral Tablet	SY	3098a080-be86-4265-9818-7fc4beab77b7	49
686429	mesalazine 1.2 GM Delayed Release Oral Tablet	SY	3098a080-be86-4265-9818-7fc4beab77b7	49

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-476-01	54092047601	120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)		2007-01-16	0000-00-00	No	No	Current
54092-476-02	54092047602	12 BOTTLE in 1 CARTON (54092-476-02) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)	12 bottle	2007-01-16	0000-00-00	No	No	Current
54092-476-08	54092047608	3 CARTON in 1 CARTON (54092-476-08) / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK	3 carton	2007-01-16	0000-00-00	No	No	Current
54092-476-12	54092047612	120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12)		2007-01-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lialda	Takeda Pharmaceuticals America, Inc. \| Sharp Packaging Services LLC \| PharmaZell GmbH \| Cosmo SpA \| PharmaZell (India) Private Ltd.	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	49