Mesalamine

Manufacturer: Zydus Lifesciences Limited
Effective date: 2025-01-09
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 21:22:23

Label at a glance#

ProductMesalamine

Active ingredientMESALAMINE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1513-6

Mesalamine suppositories, 1000 mg

30 rectal suppositories

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
248420	mesalamine 1000 MG Rectal Suppository	PSN	7
248420	mesalamine 1000 MG Rectal Suppository	SCD	7
248420	mesalazine 1000 MG Rectal Suppository	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MESALAMINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1513-6	Mesalamine	6 in 1 BLISTER PACK	SUPPOSITORY	6		7
70771-1513-7	Mesalamine	5 in 1 POUCH	SUPPOSITORY	5		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1513	MESALAMINE SUPPOSITORY [ZYDUS LIFESCIENCES LIMITED]	7	Current NDC, Legacy NDC, 2 package rows	20250110_aa63b4bb-2de7-40aa-b26b-1b00b0183eac.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Mesalamine
FAT, HARD

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1513	70771-1513-6, 70771-1513-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MESALAMINE	4Q81I59GXC	ACTIB
FAT, HARD	8334LX7S21	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208953-001	MESALAMINE	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB		2020-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208953-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208953-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-02-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208953-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208953-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208953-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208953-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208953-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208953-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208953-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208953-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208953-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208953-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208953-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208953-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208953-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208953-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208953-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208953-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208953-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208953-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208953-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208953-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208953-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208953-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208953-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208953-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208953-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208953-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208953-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208953-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208953-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208953-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208953-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208953-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208953-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208953-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208953-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208953-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208953-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208953-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208953-001	AB	1	`a50c72e98297…`

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
Mesalamine	MESALAMINE	Zydus Lifesciences Limited	aa63b4bb-2de7-40aa-b26b-1b00b0183eac	2025-01-09		Exact identifier ndc (package): 70771-1513-7 ndc (package): 70771-1513-6 ndc (product): 70771-1513 ndc11 (package): 70771151307 ndc11 (package): 70771151306 spl id: 923f1e77-becd-45e6-a9e8-12cd5942c828 spl set id: aa63b4bb-2de7-40aa-b26b-1b00b0183eac

Reported adverse events (FAERS/openFDA)#

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