ZALDYON

Product NDC: 70771-1353
11-digit product format: 707711353
Labeler code: 70771
Product ID: 70771-1353_a82b38a9-8d59-4a84-a25a-4bf479c4843d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA203286
Marketing category: ANDA
Marketing start: 2019-01-17
Marketing end: 0000-00-00
Substance: MESALAMINE
Active strength: 800 mg/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70771-1353		D	Discontinued by firm	2026-08-11
excluded package	package	70771-1353	70771-1353-4	D	Discontinued by firm	2026-08-11
excluded package	package	70771-1353	70771-1353-8	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70771-1353		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1353	70771-1353-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1353	70771-1353-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1353	ZALDYON (MESALAMINE) TABLET, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]	4	Legacy NDC	20221019_3256744b-e6fe-41d6-85b9-a705b7c7ce86.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1353-4	70771135304	10 BLISTER PACK in 1 CARTON (70771-1353-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70771-1353-2)	10 blister pack	2019-01-17	0000-00-00	No	No	Current
70771-1353-8	70771135308	180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1353-8)		2019-01-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZALDYON (mesalamine) DELAYED-RELEASE TABLETS	Zydus Lifesciences Limited	2024-12-04	HUMAN PRESCRIPTION DRUG LABEL	5