Home NDC 46708-724-91 MESALAMINE
Product NDC 46708-724
Requested package NDC 46708-724-91
11-digit product format 467080724
Labeler code 46708
Product ID 46708-724_4ef59b85-e5a5-479f-a1fe-e1cee4d87670
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MESALAMINE
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA216967
Marketing category ANDA
Marketing start 2022-11-03
Substance MESALAMINE
Active strength .375 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 A216967-001 MESALAMINE MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216967-001 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 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216967-001 MESALAMINE 375MG CAPSULE, EXTENDED RELEASE / ORAL AB 2022-10-28 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 .375 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 825130 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 46708-724-35 MESALAMINE 120 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 120 1 46708-724-91 MESALAMINE 1000 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-724 MESALAMINE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, Legacy NDC, 2 package rows 20221223_4ef59b85-e5a5-479f-a1fe-e1cee4d87670.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 Marketing end Sample Exclude flag Status 46708-724-91 46708072491 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-724-91) 2022-11-03 0000-00-00 No No Current