Home NDC 70748-214 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 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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 N022301-001 APRISO 375MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022301-001 APRISO 375MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2008-10-31 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022301-001 8865688 2030-05-01 U-1310 2014-10-22 caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 2 matching rows.
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