Home NDC 0527-3012 MESALAMINE
Product NDC 0527-3012
11-digit product format 005273012
Labeler code 0527
Product ID 0527-3012_81f0e9e6-e117-46fa-b0e6-c423f63bd3d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mesalamine
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Lannett Company Inc.
Application ANDA217337
Marketing category ANDA
Marketing start 2023-06-03
Substance MESALAMINE
Active strength 1.2 g/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 A217337-001 MESALAMINE MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217337-001 AB
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.
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 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217337-001 MESALAMINE 1.2GM TABLET, DELAYED RELEASE / ORAL AB 2023-05-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base MESALAMINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESALAMINE 1.2 g/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 686429 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-3012-48 MESALAMINE 120 in 1 BOTTLE TABLET, DELAYED RELEASE 120 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-3012 MESALAMINE TABLET, DELAYED RELEASE [LANNETT COMPANY INC.] 6 Current NDC, 1 package rows 20240417_29dbe417-15a9-4c4d-846b-81cabda7ac70.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0527-3012-48 00527301248 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-3012-48) 2023-06-03 No No Current