ZALDYON (mesalamine) DELAYED-RELEASE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-12-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 20:37:22

Label at a glance#

ProductZALDYON

Active ingredientMESALAMINE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1353-8 in bottle of 180 tablets

ZALDYON (Mesalamine) delayed-release Tablets USP, 800 mg

R_xonly

180 tablets

ZYDUS

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

ZALDYON
mesalamine
ACETYLTRIBUTYL CITRATE
SILICON DIOXIDE
FERRIC OXIDE RED
MAGNESIUM STEARATE
METHACRYLIC ACID
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
SHELLAC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1353	70771-1353-2, 70771-1353-4, 70771-1353-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MESALAMINE	4Q81I59GXC	ACTIB
ACETYLTRIBUTYL CITRATE	0ZBX0N59RZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHACRYLIC ACID	1CS02G8656	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
AMMONIA	5138Q19F1X	IACT
SHELLAC	46N107B71O	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
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 · 43 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
2026-09-14 22:38:34	2026-08	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203286-001	MESALAMINE	800MG	TABLET, DELAYED RELEASE / ORAL	AB	RS	2017-07-21	`caaa826d4ba7…`
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…`

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	A203286-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203286-001	AB	1	`caaa826d4ba7…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
12c15d1d-278c-4dbf-a6f6-7ccca03a9d94			3256744b-e6fe-41d6-85b9-a705b7c7ce86	2025-09-19		Exact identifier spl set id: 3256744b-e6fe-41d6-85b9-a705b7c7ce86

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.