mesalamine

Product NDC: 70748-214
11-digit product format: 707480214
Labeler code: 70748
Product ID: 70748-214_df59b373-25c0-4eb6-a475-44a99a9b9101
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mesalamine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: NDA022301
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-05-18
Marketing end: 0000-00-00
Substance: MESALAMINE
Active strength: 375 mg/1
Pharmacologic classes: Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70748-214		D	Discontinued by firm		2026-08-07
excluded package	package	70748-214	70748-214-16	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70748-214		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70748-214	70748-214-16	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70748-214-16	EA - Each	70748-214	de1fd085-abb7-4a25-8c2f-ef743a6e343e	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70748-214	MESALAMINE CAPSULE, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	8	Legacy NDC	20240112_a69ce2b9-2866-406d-a365-5b185a269e3e.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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Q81I59GXC	MESALAMINE	89-57-6	MESALAMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70748-214-16	70748021416	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-214-16)	2020-05-18	0000-00-00	No	No	Current