mesalamine

Product NDC: 68682-113
11-digit product format: 686820113
Labeler code: 68682
Product ID: 68682-113_0ce2b1db-0b45-4548-e063-6294a90a84f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: NDA022301
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-07-19
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: mesalamine
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
825130	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
cfe4800f-868f-46fd-8b9a-977a91ae5fbe	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
68682-113-20	mesalamine	1 in 1 CARTON	CAPSULE, EXTENDED RELEASE	1		9
68682-113-20	mesalamine	120 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	120		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-113-20	EA - Each	68682-113	85dc4690-81d4-490a-aad9-93e61dc29851	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-113	MESALAMINE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 2 package rows	20231220_cfe4800f-868f-46fd-8b9a-977a91ae5fbe.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
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 ndc (product): 68682-113

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
825130	mesalamine 0.375 GM 24HR Extended Release Oral Capsule	PSN	cfe4800f-868f-46fd-8b9a-977a91ae5fbe	9
825130	24 HR mesalamine 375 MG Extended Release Oral Capsule	SCD	cfe4800f-868f-46fd-8b9a-977a91ae5fbe	9
825130	mesalamine 375 MG 24 HR Extended Release Oral Capsule	SY	cfe4800f-868f-46fd-8b9a-977a91ae5fbe	9
825130	mesalazine 375 MG 24 HR Extended Release Oral Capsule	SY	cfe4800f-868f-46fd-8b9a-977a91ae5fbe	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-113-20	68682011320	1 BOTTLE in 1 CARTON (68682-113-20) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2018-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
mesalamine	Oceanside Pharmaceuticals \| Catalent Pharma Solutions, LLC \| Bausch Health Companies Inc.	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	9