Mesalamine

Product NDC: 45802-929
11-digit product format: 458020929
Labeler code: 45802
Product ID: 45802-929_5c0cc687-bc62-4ae2-adae-aeb4a5d608bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mesalamine
Dosage form: KIT
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA076751
Marketing category: ANDA
Marketing start: 2018-08-02
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
A076751-001	MESALAMINE	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB		2004-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076751-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076751-001	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	2004-09-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076751-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076751-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076751-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076751-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076751-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076751-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076751-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076751-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076751-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076751-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076751-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076751-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076751-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076751-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076751-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076751-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076751-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076751-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076751-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076751-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076751-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076751-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076751-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076751-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076751-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076751-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076751-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076751-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076751-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076751-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076751-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076751-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076751-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076751-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076751-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076751-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076751-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076751-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076751-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076751-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mesalamine
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238151	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
b2a5b110-7537-4ffc-bf0a-f0fe13379c9d	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
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
a4dbd90c-f616-c999-40d7-60da88952163	Product name	2	20190802
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
45802-098-46	Mesalamine	60 mL in 1 BOTTLE	ENEMA	420 mL	4 g in 60mL	8
45802-929-49	Mesalamine	1 in 1 CARTON	KIT	1		8
45802-929-49	Mesalamine	4 in 1 KIT	KIT	4		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-929-49	EA - Each	45802-929	7c981a11-9d91-4343-af47-dd61f304c0d0	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-929	MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]	8	Current NDC, Legacy NDC, 3 package rows	20241017_b2a5b110-7537-4ffc-bf0a-f0fe13379c9d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mesalamine	MESALAMINE	Bryant Ranch Prepack	1e561474-6169-410e-b83d-7e96d375831d	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751
Mesalamine	MESALAMINE	Bryant Ranch Prepack	9756d07b-2939-460f-94d3-e338c28cb993	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	b2a5b110-7537-4ffc-bf0a-f0fe13379c9d	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751 ndc (product): 45802-929
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	d50f2c37-5675-49f3-bdd4-3b16d333ed40	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751
Mesalamine	MESALAMINE	Padagis Israel Pharmaceuticals Ltd	a4ddf68d-1502-4242-89aa-c96436bdcbf6	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076751 application number: ANDA076751

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
238151	mesalamine 4 GM in 60 mL Enema	PSN	1e561474-6169-410e-b83d-7e96d375831d	106
238151	mesalamine 66.7 MG/ML Enema	SCD	1e561474-6169-410e-b83d-7e96d375831d	106
238151	mesalamine 4 GM per 60 ML Enema	SY	1e561474-6169-410e-b83d-7e96d375831d	106
238151	mesalazine 66.7 MG/ML Enema	SY	1e561474-6169-410e-b83d-7e96d375831d	106
238151	mesalamine 4 GM in 60 mL Enema	PSN	b2a5b110-7537-4ffc-bf0a-f0fe13379c9d	8
238151	mesalamine 66.7 MG/ML Enema	SCD	b2a5b110-7537-4ffc-bf0a-f0fe13379c9d	8
238151	mesalamine 4 GM per 60 ML Enema	SY	b2a5b110-7537-4ffc-bf0a-f0fe13379c9d	8
238151	mesalazine 66.7 MG/ML Enema	SY	b2a5b110-7537-4ffc-bf0a-f0fe13379c9d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-098-46	45802009846	60 mL in 1 BOTTLE	60 ml					Historical
45802-929-49	45802092949	4 CARTON in 1 KIT (45802-929-49) / 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET	4 carton	2018-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mesalamine Rectal Suspension, USP Enema	Bryant Ranch Prepack	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	106
Mesalamine	Padagis Israel Pharmaceuticals Ltd	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	8
Mesalamine Rectal Suspension, USP Enema 4g/unit (60 mL)	Perrigo New York Inc	2018-08-16	HUMAN PRESCRIPTION DRUG LABEL	1