Asacol

Product NDC: 53808-0205
11-digit product format: 538080205
Labeler code: 53808
Product ID: 53808-0205_bac1e923-6161-462a-bfd3-37cfb34a7313
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: NDA019651
Marketing category: NDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: MESALAMINE
Active strength: 400 mg/1
Pharmacologic classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0205		I	Inactivated by FDA		2026-08-17
excluded package	package	53808-0205	53808-0205-1	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0205-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0205-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0205-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0205-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0205-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0205-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0205-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0205-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0205-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0205-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0205-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0205-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0205-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0205-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0205-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0205-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0205-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0205-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0205-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0205-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0205-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0205-1	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N019651-001	ASACOL	MESALAMINE	400MG	TABLET, DELAYED RELEASE / ORAL			1992-01-31

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019651-001	ASACOL	400MG	TABLET, DELAYED RELEASE / ORAL	1992-01-31	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0205-1	2019-10-21	C162847	48780-1	956f9ecf-da6a-621f-e053-dbdaa90a74ad	Asacol ® (mesalamine) Delayed-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0205-1	Asacol	30 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	30		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MESALAMINE	ACTIVE INGREDIENT	4Q81I59GXC	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
mesalamine	ACTIVE MOIETY	4Q81I59GXC	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0205	ASACOL (MESALAMINE) TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2	Legacy NDC, 1 package rows	20100324_83864c82-9114-4523-bab8-2b47beb88d4e.zip

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
104112	Asacol 400 MG Delayed Release Oral Tablet	PSN	83864c82-9114-4523-bab8-2b47beb88d4e	2
311550	mesalamine 400 MG Delayed Release Oral Tablet	PSN	83864c82-9114-4523-bab8-2b47beb88d4e	2
104112	mesalamine 400 MG Delayed Release Oral Tablet [Asacol]	SBD	83864c82-9114-4523-bab8-2b47beb88d4e	2
311550	mesalamine 400 MG Delayed Release Oral Tablet	SCD	83864c82-9114-4523-bab8-2b47beb88d4e	2
104112	Asacol 400 MG Delayed Release Oral Tablet	SY	83864c82-9114-4523-bab8-2b47beb88d4e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0205-1	53808020501	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Asacol ® (mesalamine) Delayed-Release Tablets	State of Florida DOH Central Pharmacy	2010-03-12	HUMAN PRESCRIPTION DRUG LABEL	2