Home NDC 45802-098 Mesalamine
Product NDC 45802-098
11-digit product format 458020098
Labeler code 45802
Product ID 45802-098_f416ded9-2018-4422-8cff-c6fc563a3772
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form ENEMA
Route RECTAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA076751
Marketing category ANDA
Marketing start 2007-10-11
Substance MESALAMINE
Active strength 4 g/60mL
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A076751-001 MESALAMINE MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076751-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076751-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2004-09-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mesalamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESALAMINE 4 g/60mL
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 238151 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-098 MESALAMINE KIT [BRYANT RANCH PREPACK] 106 Current NDC, Legacy NDC 20241109_1e561474-6169-410e-b83d-7e96d375831d.zip 45802-098 MESALAMINE KIT [BRYANT RANCH PREPACK] 106 Current NDC, Legacy NDC 20241109_9756d07b-2939-460f-94d3-e338c28cb993.zip 45802-098 MESALAMINE ENEMA [PADAGIS ISRAEL PHARMACEUTICALS LTD] 14 Current NDC, Legacy NDC, 5 package rows 20250224_a4ddf68d-1502-4242-89aa-c96436bdcbf6.zip 45802-098 MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD] 14 Current NDC, Legacy NDC 20241017_d50f2c37-5675-49f3-bdd4-3b16d333ed40.zip 45802-098 MESALAMINE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD] 8 Current NDC, Legacy NDC 20241017_b2a5b110-7537-4ffc-bf0a-f0fe13379c9d.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45802-098-28 45802009828 28 BOTTLE in 1 CARTON (45802-098-28) / 60 mL in 1 BOTTLE 28 bottle 2008-02-12 0000-00-00 No No Current 45802-098-46 45802009846 60 mL in 1 BOTTLE (45802-098-46) 60 ml 2007-10-11 0000-00-00 No No Current 45802-098-51 45802009851 7 BOTTLE in 1 CARTON (45802-098-51) / 60 mL in 1 BOTTLE 7 bottle 2007-10-11 0000-00-00 No No Current