Mesalamine

Product NDC: 70771-1625
11-digit product format: 707711625
Labeler code: 70771
Product ID: 70771-1625_e6ae9f47-11d7-4676-b1ae-0c4f4d1830c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mesalamine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA208954
Marketing category: ANDA
Marketing start: 2021-08-13
Substance: MESALAMINE
Active strength: .375 g/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A208954-001	MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2021-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208954-001	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
2026-02-19 14:30 UTC	2026-02	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208954-001	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-12	`a50c72e98297…`

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	A208954-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208954-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208954-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208954-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208954-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208954-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208954-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208954-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208954-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208954-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208954-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208954-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208954-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208954-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208954-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208954-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208954-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208954-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208954-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208954-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208954-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208954-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208954-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208954-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208954-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208954-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208954-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208954-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208954-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208954-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208954-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208954-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208954-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mesalamine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	.375 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
825130	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
04073681-a834-4f45-91c5-224b608b30e6	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3	Product name	1	20230124
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
70771-1625-7	Mesalamine	120 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	120		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1625	MESALAMINE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, Legacy NDC, 1 package rows	20241204_04073681-a834-4f45-91c5-224b608b30e6.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
Mesalamine	MESALAMINE	Zydus Lifesciences Limited	04073681-a834-4f45-91c5-224b608b30e6	2024-11-30		Exact identifier application applno (ANDA): 208954 application number: ANDA208954 ndc (product): 70771-1625
Mesalamine	MESALAMINE	Zydus Pharmaceuticals USA Inc.	cd8493f7-91fd-4c2d-b3d7-c1301825586b	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208954 application number: ANDA208954

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
825130	mesalamine 0.375 GM 24HR Extended Release Oral Capsule	PSN	04073681-a834-4f45-91c5-224b608b30e6	3
825130	24 HR mesalamine 375 MG Extended Release Oral Capsule	SCD	04073681-a834-4f45-91c5-224b608b30e6	3
825130	mesalamine 375 MG 24 HR Extended Release Oral Capsule	SY	04073681-a834-4f45-91c5-224b608b30e6	3
825130	mesalazine 375 MG 24 HR Extended Release Oral Capsule	SY	04073681-a834-4f45-91c5-224b608b30e6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1625-7	70771162507	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1625-7)	2021-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MESALAMINE Extended-Release Capsules	Zydus Lifesciences Limited	2024-11-30	HUMAN PRESCRIPTION DRUG LABEL	3