Mesalamine

Product NDC: 0472-1915
11-digit product format: 004721915
Labeler code: 0472
Product ID: 0472-1915_380df1f0-2282-4c49-bd7c-40b244f875d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mesalamine
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Actavis Pharma, Inc.
Application: ANDA205654
Marketing category: ANDA
Marketing start: 2021-04-23
Marketing end: 2026-11-30
Substance: MESALAMINE
Active strength: 1000 mg/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Current FDA listing: Yes

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
A205654-001	MESALAMINE	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB		2020-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205654-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205654-001	MESALAMINE	1GM	SUPPOSITORY / RECTAL	AB	2020-08-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205654-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205654-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205654-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205654-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205654-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205654-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205654-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205654-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205654-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205654-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205654-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205654-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205654-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205654-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205654-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205654-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205654-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205654-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205654-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205654-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205654-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205654-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205654-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205654-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205654-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205654-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205654-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205654-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205654-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205654-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205654-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205654-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205654-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205654-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205654-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205654-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205654-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205654-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mesalamine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	1000 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
248420	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
73317da3-cba0-4106-9e88-79b0e2f642af	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	Strength	SPL version
0472-1915-01	Mesalamine	1 in 1 POUCH	SUPPOSITORY	1		9
0472-1915-30	Mesalamine	30 in 1 BOX	SUPPOSITORY	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-1915-01	EA - Each	0472-1915	8993fc09-1fba-4d33-840d-faf73a81192d	1	2021-05-05
0472-1915-30	EA - Each	0472-1915	f951b91e-b4bf-4b31-8999-baecff5a7360	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-1915	MESALAMINE SUPPOSITORY [ACTAVIS PHARMA, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20231218_73317da3-cba0-4106-9e88-79b0e2f642af.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mesalamine	MESALAMINE	Actavis Pharma, Inc.	73317da3-cba0-4106-9e88-79b0e2f642af	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205654 application number: ANDA205654 ndc (product): 0472-1915

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
248420	mesalamine 1000 MG Rectal Suppository	PSN	73317da3-cba0-4106-9e88-79b0e2f642af	9
248420	mesalamine 1000 MG Rectal Suppository	SCD	73317da3-cba0-4106-9e88-79b0e2f642af	9
248420	mesalazine 1000 MG Rectal Suppository	SY	73317da3-cba0-4106-9e88-79b0e2f642af	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-1915-01	00472191501	1 in 1 POUCH						Historical
0472-1915-30	00472191530	30 POUCH in 1 BOX (0472-1915-30) / 1 SUPPOSITORY in 1 POUCH (0472-1915-01)	30 pouch	2021-04-23	2026-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mesalamine - Actavis Pharma, Inc.	Actavis Pharma, Inc.	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	9