MESALAMINE DELAYED-RELEASE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 21:18:31

Label at a glance#

Productmesalamine

Active ingredientMESALAMINE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1071-1

Mesalamine Delayed-release Tablets, 1.2 g

Rx only

120 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
686429	mesalamine 1.2 GM Delayed Release Oral Tablet, Once-Daily	PSN	7
686429	mesalamine 1200 MG Delayed Release Oral Tablet	SCD	7
686429	mesalazine 1.2 GM Delayed Release Oral Tablet	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
70771-1071-1	mesalamine	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120		7
70771-1071-2	mesalamine	34 in 1 BOTTLE	TABLET, DELAYED RELEASE	34		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1071	MESALAMINE TABLET, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]	7	Current NDC, Legacy NDC, 2 package rows	20241204_29c0dd58-d2cf-40fa-bc32-0eab61937331.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

mesalamine
CARBOXYMETHYLCELLULOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
MAGNESIUM STEARATE
METHACRYLIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1071	70771-1071-2, 70771-1071-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MESALAMINE	4Q81I59GXC	ACTIB
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHACRYLIC ACID	1CS02G8656	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	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
A091640-001	MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB		2017-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091640-001	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 · 43 observed 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	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091640-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2017-06-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091640-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091640-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091640-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091640-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091640-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091640-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091640-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091640-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091640-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091640-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091640-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091640-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091640-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091640-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091640-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091640-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091640-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091640-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091640-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091640-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091640-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091640-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091640-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091640-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091640-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091640-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091640-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091640-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091640-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091640-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091640-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091640-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091640-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091640-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091640-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091640-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091640-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091640-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091640-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091640-001	AB	1	`f41ea6bd6efb…`

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	29c0dd58-d2cf-40fa-bc32-0eab61937331	2024-11-30		Exact identifier ndc (package): 70771-1071-1 ndc (package): 70771-1071-2 ndc (product): 70771-1071 ndc11 (package): 70771107102 ndc11 (package): 70771107101 spl id: 26f195e7-e73a-48e7-b3b0-49f7cbed510a spl set id: 29c0dd58-d2cf-40fa-bc32-0eab61937331

Reported adverse events (FAERS/openFDA)#

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