mesalamine

Product NDC: 68382-435
11-digit product format: 683820435
Labeler code: 68382
Product ID: 68382-435_c2b40002-6c58-4c89-b178-c915a59cb2dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA203286
Marketing category: ANDA
Marketing start: 2018-08-02
Substance: MESALAMINE
Active strength: 800 mg/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
A203286-001	MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203286-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL		RS	2017-07-21	`cb3db0bc1861…`

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	A203286-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203286-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203286-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203286-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203286-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203286-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203286-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203286-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203286-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203286-001	AB	1	`d06236e962d9…`
2022-04-08 23:34 UTC	2022-04	A203286-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203286-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203286-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203286-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203286-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203286-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203286-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203286-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203286-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203286-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203286-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203286-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203286-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: mesalamine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	800 mg/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
833234	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
ad8c7930-92e2-4372-a874-da22b9ae333e	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
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	SPL version
68382-435-28	mesalamine	180 in 1 BOTTLE	TABLET, DELAYED RELEASE	180	8
68382-435-30	mesalamine	10 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	10	8
68382-435-77	mesalamine	10 in 1 CARTON	TABLET, DELAYED RELEASE	10	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-435-28	EA - Each	68382-435	92a8c750-b696-42b2-bd86-a9594111b41c	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-435	MESALAMINE TABLET, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 3 package rows	20230812_ad8c7930-92e2-4372-a874-da22b9ae333e.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mesalamine	MESALAMINE	Zydus Pharmaceuticals USA Inc.	ad8c7930-92e2-4372-a874-da22b9ae333e	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203286 application number: ANDA203286 ndc (product): 68382-435
mesalamine	MESALAMINE	Zydus Lifesciences Limited	52d96501-47f3-45d8-a181-98763b9f8965	2024-11-30		Exact identifier application applno (ANDA): 203286 application number: ANDA203286
Mesalamine	MESALAMINE	American Health Packaging	a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203286 application number: ANDA203286

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
833234	mesalamine 800 MG Delayed Release Oral Tablet	PSN	ad8c7930-92e2-4372-a874-da22b9ae333e	8
833234	mesalamine 800 MG Delayed Release Oral Tablet	SCD	ad8c7930-92e2-4372-a874-da22b9ae333e	8
833234	mesalazine 800 MG Delayed Release Oral Tablet	SY	ad8c7930-92e2-4372-a874-da22b9ae333e	8
833234	mesalamine 800 MG Delayed Release Oral Tablet	PSN	a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb	6
833234	mesalamine 800 MG Delayed Release Oral Tablet	SCD	a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb	6
833234	mesalazine 800 MG Delayed Release Oral Tablet	SY	a74ab9f4-ffcd-4bbf-88a5-342e6a38aabb	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-435-28	68382043528	180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)		2018-08-02	0000-00-00	No	No	Current
68382-435-30	68382043530	10 in 1 BLISTER PACK						Historical
68382-435-77	68382043577	10 BLISTER PACK in 1 CARTON (68382-435-77) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)	10 blister pack	2018-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
mesalamine	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	9
Mesalamine	American Health Packaging	2024-11-21	HUMAN PRESCRIPTION DRUG LABEL	6