sfRowasa

Product NDC: 0037-0022
Requested package NDC: 0037-0022-28
11-digit product format: 000370022
Labeler code: 0037
Product ID: 0037-0022_37493a98-a4eb-42d3-8eff-5bf90c4a7f26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: SUSPENSION
Route: RECTAL
Labeler: Viatris Specialty LLC
Application: NDA019618
Marketing category: NDA
Marketing start: 2016-03-24
Marketing end: 2026-07-31
Substance: MESALAMINE
Active strength: 4 g/60mL
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0037-0022	0037-0022-28	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019618-001	ROWASA	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24
N019618-002	SFROWASA	MESALAMINE	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N019618-001	AB
N019618-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N019618-002	7645801	2027-07-24		Drug substance, Drug product

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 3 · 82 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	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019618-001	ROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD, RS	1987-12-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019618-002	SFROWASA	4GM/60ML	ENEMA / RECTAL	AB	RLD	2008-06-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N019618-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019618-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019618-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019618-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019618-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019618-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019618-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019618-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019618-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019618-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019618-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019618-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019618-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019618-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019618-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019618-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019618-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019618-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019618-002	7645801	2027-07-24	Drug substance, Drug product	`cb3db0bc1861…`

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
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	SPL version
0037-0022-07	sfRowasaSulfite-Free Formulation	7 in 1 CARTON	SUSPENSION	7	12
0037-0022-28	sfRowasaSulfite-Free Formulation	28 in 1 CARTON	SUSPENSION	28	12
0037-0022-60	sfRowasaSulfite-Free Formulation	60 mL in 1 BOTTLE, WITH APPLICATOR	SUSPENSION	60	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-0022-07	ML - Milliliter	0037-0022	b655b60a-54da-4a52-9309-b8c37f9de1e5	1	2016-05-16
0037-0022-28	ML - Milliliter	0037-0022	7634d71d-2b91-4464-8ee2-7e62cde43633	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0037-0022	SFROWASA SULFITE-FREE FORMULATION (MESALAMINE) SUSPENSION [MEDA PHARMACEUTICALS INC.]	10	Current NDC, Legacy NDC, 3 package rows	20241011_aa273fdc-f7c4-4901-8f71-59ae03b8cdb1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rowasa	MESALAMINE	Viatris Specialty LLC	e505ab99-1943-4216-a178-4d5dbe64e3b2	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019618 application number: NDA019618
Mesalamine	MESALAMINE	ANI Pharmaceuticals, Inc.	3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019618 application number: NDA019618

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	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12
206798	sfRowasa 4 GM in 60 mL Enema	PSN	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12
206798	mesalamine 66.7 MG/ML Enema [Rowasa]	SBD	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12
238151	mesalamine 66.7 MG/ML Enema	SCD	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12
238151	mesalamine 4 GM per 60 ML Enema	SY	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12
238151	mesalazine 66.7 MG/ML Enema	SY	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12
206798	Rowasa 4 GM per 60 ML Enema	SY	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12
206798	Rowasa 66.7 MG/ML Enema	SY	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12
206798	sfRowasa 4 GM per 60 ML Enema	SY	aa273fdc-f7c4-4901-8f71-59ae03b8cdb1	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0037-0022-28	00037002228	28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) / 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)	2016-05-24	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
sfRowasa Sulfite-Free Formulation	Viatris Specialty LLC	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	12