APRISO

Product NDC: 65649-103
11-digit product format: 656490103
Labeler code: 65649
Product ID: 65649-103_0e88852d-72fc-3002-e063-6394a90a0369
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Salix Pharmaceuticals, Inc.
Application: NDA022301
Marketing category: NDA
Marketing start: 2008-10-31
Substance: MESALAMINE
Active strength: 375 mg/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
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
N022301-001	APRISO	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022301-001	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
N022301-001	8865688	2030-05-01	U-1310		2014-10-22

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2008-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2008-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2008-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022301-001	APRISO	375MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022301-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022301-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022301-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022301-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022301-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022301-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022301-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022301-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022301-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022301-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022301-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022301-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022301-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022301-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022301-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022301-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022301-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022301-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022301-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022301-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022301-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022301-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022301-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022301-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022301-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022301-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022301-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022301-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022301-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022301-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022301-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022301-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022301-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022301-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022301-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022301-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022301-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022301-001	AB	1	`a50c72e98297…`

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	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022301-001	8865688	2030-05-01	U-1310	2014-10-22	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MESALAMINE	375 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
825130	Internal RxNorm lookup
825134	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
7951139c-b271-45a4-b523-34b23800917b	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	SPL version
65649-103-01	APRISO	1 in 1 CARTON	CAPSULE, EXTENDED RELEASE	1	34
65649-103-01	APRISO	4 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	4	34
65649-103-02	APRISO	120 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	120	34
65649-103-02	APRISO	1 in 1 CARTON	CAPSULE, EXTENDED RELEASE	1	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65649-103-02	EA - Each	65649-103	015fe0a2-3ab7-45ff-a42d-660a95ced15d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MESALAMINE	ACTIVE INGREDIENT	4Q81I59GXC	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
MESALAMINE	ACTIVE MOIETY	4Q81I59GXC	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	14
MESALAMINE	ACTIVE INGREDIENT	4Q81I59GXC	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
MESALAMINE	ACTIVE MOIETY	4Q81I59GXC	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65649-103	APRISO (MESALAMINE) CAPSULE, EXTENDED RELEASE [SALIX PHARMACEUTICALS, INC.]	34	Current NDC, Legacy NDC, 4 package rows	20240110_7951139c-b271-45a4-b523-34b23800917b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
APRISO	MESALAMINE	Salix Pharmaceuticals, Inc.	7951139c-b271-45a4-b523-34b23800917b	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022301 application number: NDA022301 ndc (product): 65649-103
mesalamine	MESALAMINE	Teva Pharmaceuticals USA, Inc.	8d27a608-3ba1-4799-be38-c00fb08ce3ce	2023-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022301 application number: NDA022301
mesalamine	MESALAMINE	Oceanside Pharmaceuticals	cfe4800f-868f-46fd-8b9a-977a91ae5fbe	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022301 application number: NDA022301

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
825134	Apriso 0.375 GM 24HR Extended Release Oral Capsule	PSN	7951139c-b271-45a4-b523-34b23800917b	34
825130	mesalamine 0.375 GM 24HR Extended Release Oral Capsule	PSN	7951139c-b271-45a4-b523-34b23800917b	34
825134	24 HR mesalamine 375 MG Extended Release Oral Capsule [Apriso]	SBD	7951139c-b271-45a4-b523-34b23800917b	34
825130	24 HR mesalamine 375 MG Extended Release Oral Capsule	SCD	7951139c-b271-45a4-b523-34b23800917b	34
825134	Apriso 375 MG 24 HR Extended Release Oral Capsule	SY	7951139c-b271-45a4-b523-34b23800917b	34
825130	mesalamine 375 MG 24 HR Extended Release Oral Capsule	SY	7951139c-b271-45a4-b523-34b23800917b	34
825130	mesalazine 375 MG 24 HR Extended Release Oral Capsule	SY	7951139c-b271-45a4-b523-34b23800917b	34
825134	Apriso 0.375 GM 24HR Extended Release Oral Capsule	PSN	d5d05b1f-9f45-4f66-9f75-3c67934105de	2
825130	mesalamine 0.375 GM 24HR Extended Release Oral Capsule	PSN	d5d05b1f-9f45-4f66-9f75-3c67934105de	2
825134	24 HR mesalamine 375 MG Extended Release Oral Capsule [Apriso]	SBD	d5d05b1f-9f45-4f66-9f75-3c67934105de	2
825130	24 HR mesalamine 375 MG Extended Release Oral Capsule	SCD	d5d05b1f-9f45-4f66-9f75-3c67934105de	2
825134	Apriso 375 MG 24 HR Extended Release Oral Capsule	SY	d5d05b1f-9f45-4f66-9f75-3c67934105de	2
825130	mesalamine 375 MG 24 HR Extended Release Oral Capsule	SY	d5d05b1f-9f45-4f66-9f75-3c67934105de	2
825130	mesalazine 375 MG 24 HR Extended Release Oral Capsule	SY	d5d05b1f-9f45-4f66-9f75-3c67934105de	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65649-103-01	65649010301	1 BOTTLE in 1 CARTON (65649-103-01) / 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2008-10-31	0000-00-00	Yes	No	Current
65649-103-02	65649010302	1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2008-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
APRISO	Salix Pharmaceuticals, Inc. \| Catalent Pharma Solutions, LLC \| Bausch Health Companies Inc.	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	34
APRISO	Aphena Pharma Solutions - Tennessee, LLC	2017-12-14	HUMAN PRESCRIPTION DRUG LABEL	1
APRISO	Physicians Total Care, Inc.	2012-02-15	HUMAN PRESCRIPTION DRUG LABEL	2