Rowasa

Product NDC: 0037-0066
11-digit product format: 000370066
Labeler code: 0037
Product ID: 0037-0066_b6652e84-f693-4388-bd29-21e035ffe4a9
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
Substance: MESALAMINE
Active strength: 4 g/60mL
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rowasa
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	4 g/60mL

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e505ab99-1943-4216-a178-4d5dbe64e3b2	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
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
0037-0066-03	Rowasa	28 in 1 CARTON	SUSPENSION	28	17
0037-0066-05	Rowasa	7 in 1 CARTON	SUSPENSION	7	17
0037-0066-06	Rowasa	60 mL in 1 BOTTLE, DISPENSING	SUSPENSION	60	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-0066-03	EA - Each	0037-0066	e5b4b8d1-d276-4bb3-97c9-866368916375	1	2016-07-19
0037-0066-05	EA - Each	0037-0066	693a9b62-f4ee-4b77-8fd6-7920d13a3ca9	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0037-0066	ROWASA (MESALAMINE) SUSPENSION [MEDA PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 3 package rows	20241004_e505ab99-1943-4216-a178-4d5dbe64e3b2.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 ndc (product): 0037-0066
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	e505ab99-1943-4216-a178-4d5dbe64e3b2	17
206798	sfRowasa 4 GM in 60 mL Enema	PSN	e505ab99-1943-4216-a178-4d5dbe64e3b2	17
206798	mesalamine 66.7 MG/ML Enema [Rowasa]	SBD	e505ab99-1943-4216-a178-4d5dbe64e3b2	17
238151	mesalamine 66.7 MG/ML Enema	SCD	e505ab99-1943-4216-a178-4d5dbe64e3b2	17
238151	mesalamine 4 GM per 60 ML Enema	SY	e505ab99-1943-4216-a178-4d5dbe64e3b2	17
238151	mesalazine 66.7 MG/ML Enema	SY	e505ab99-1943-4216-a178-4d5dbe64e3b2	17
206798	Rowasa 4 GM per 60 ML Enema	SY	e505ab99-1943-4216-a178-4d5dbe64e3b2	17
206798	Rowasa 66.7 MG/ML Enema	SY	e505ab99-1943-4216-a178-4d5dbe64e3b2	17
206798	sfRowasa 4 GM per 60 ML Enema	SY	e505ab99-1943-4216-a178-4d5dbe64e3b2	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0037-0066-03	00037006603	28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)		2016-03-24	0000-00-00	No	No	Current
0037-0066-05	00037006605	7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) / 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)		2016-03-24	2027-07-31	No	No	Current
0037-0066-06	00037006606	60 mL in 1 BOTTLE, DISPENSING	60 ml					Historical