Home NDC 42291-489 Mesalamine
Product NDC 42291-489
11-digit product format 422910489
Labeler code 42291
Product ID 42291-489_485f7bde-a4c9-b05b-e063-6394a90a34cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler AvKARE
Application ANDA213191
Marketing category ANDA
Marketing start 2024-09-25
Substance MESALAMINE
Active strength 800 mg/1
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A213191-001 MESALAMINE MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213191-001 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 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213191-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2024-08-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Mesalamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESALAMINE 800 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 833234 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 42291-489-18 Mesalamine 180 in 1 BOTTLE TABLET, DELAYED RELEASE 180 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-489 MESALAMINE TABLET, DELAYED RELEASE [AVKARE] 1 Current NDC, 1 package rows 20240927_22f3ee49-ac57-84f5-e063-6394a90aae91.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42291-489-18 42291048918 180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-489-18) 2024-09-25 No No Current