Mesalamine

Product NDC: 0591-2245
11-digit product format: 005912245
Labeler code: 0591
Product ID: 0591-2245_1300887a-c110-46b3-a8be-cfceabf0cbf2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mesalamine
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA203817
Marketing category: ANDA
Marketing start: 2018-03-26
Substance: MESALAMINE
Active strength: 1.2 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
A203817-001	MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB		2018-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203817-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203817-001	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE / ORAL	AB	2018-03-23	`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	A203817-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203817-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203817-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203817-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203817-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203817-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203817-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203817-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203817-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203817-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203817-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203817-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203817-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203817-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203817-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203817-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203817-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203817-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203817-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203817-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203817-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203817-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203817-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203817-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203817-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203817-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203817-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203817-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203817-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203817-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203817-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203817-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203817-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203817-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203817-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203817-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203817-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203817-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203817-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203817-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
ba1e3bd4-fbe0-46a5-961e-167ccb09672c	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3	Product name	1	20230124
a4dbd90c-f616-c999-40d7-60da88952163	Product name	2	20190802
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
77831c26-5062-ed63-fc15-a07600377b5b	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-2245-22	Mesalamine	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2245-22	EA - Each	0591-2245	b834f48d-d67c-4edf-9cc8-381ac4069b99	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2245	MESALAMINE TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	24	Current NDC, Legacy NDC, 1 package rows	20250416_ba1e3bd4-fbe0-46a5-961e-167ccb09672c.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	Actavis Pharma, Inc.	ba1e3bd4-fbe0-46a5-961e-167ccb09672c	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203817 application number: ANDA203817 ndc (product): 0591-2245
Mesalamine	MESALAMINE	Bryant Ranch Prepack	baa76dde-3c5b-4ff4-ba0c-f19660a796c1	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203817 application number: ANDA203817

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
686429	mesalamine 1.2 GM Delayed Release Oral Tablet, Once-Daily	PSN	baa76dde-3c5b-4ff4-ba0c-f19660a796c1	102
686429	mesalamine 1200 MG Delayed Release Oral Tablet	SCD	baa76dde-3c5b-4ff4-ba0c-f19660a796c1	102
686429	mesalazine 1.2 GM Delayed Release Oral Tablet	SY	baa76dde-3c5b-4ff4-ba0c-f19660a796c1	102
686429	mesalamine 1.2 GM Delayed Release Oral Tablet, Once-Daily	PSN	ba1e3bd4-fbe0-46a5-961e-167ccb09672c	25
686429	mesalamine 1200 MG Delayed Release Oral Tablet	SCD	ba1e3bd4-fbe0-46a5-961e-167ccb09672c	25
686429	mesalazine 1.2 GM Delayed Release Oral Tablet	SY	ba1e3bd4-fbe0-46a5-961e-167ccb09672c	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2245-22	00591224522	120 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2245-22)	2018-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mesalamine	Actavis Pharma, Inc.	2025-03-27	HUMAN PRESCRIPTION DRUG LABEL	25
Mesalamine	Bryant Ranch Prepack	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	102
Mesalamine	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	2