Mesalamine

Product NDC: 84612-175
11-digit product format: 846120175
Labeler code: 84612
Product ID: 84612-175_5352a04b-3756-6513-e063-6294a90a7c0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mesalamine
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Nuvaila Limited
Application: ANDA211858
Marketing category: ANDA
Marketing start: 2026-07-01
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 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
A211858-001	MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB		2019-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211858-001	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	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2019-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2019-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL		2019-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211858-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2019-01-25	`f41ea6bd6efb…`

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	A211858-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211858-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211858-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211858-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211858-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211858-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211858-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211858-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211858-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211858-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211858-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211858-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211858-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211858-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211858-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211858-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211858-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211858-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211858-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211858-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211858-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211858-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211858-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211858-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211858-001	AB	1	`c0c555d07b60…`
2019-07-19 19:46 UTC	2019-07	A211858-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211858-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211858-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211858-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211858-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211858-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211858-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211858-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211858-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211858-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211858-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211858-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211858-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211858-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211858-001	AB	1	`a50c72e98297…`

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
875d573f-99a1-426a-8321-4d511690d503	Available on FDA.report

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	Nuvaila Limited	875d573f-99a1-426a-8321-4d511690d503	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211858 application number: ANDA211858 ndc (product): 84612-175
Mesalamine	MESALAMINE	Sun Pharmaceutical Industries, Inc.	fd8b02de-7dfa-444d-a1f8-1436b578e0cb	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211858 application number: ANDA211858

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Q81I59GXC	MESALAMINE	89-57-6	MESALAMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84612-175-13	84612017513	120 TABLET, DELAYED RELEASE in 1 BOTTLE (84612-175-13)	2026-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mesalamine	Nuvaila Limited \| Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	1