Home NDC 21922-045 Mesalamine
Product NDC 21922-045
11-digit product format 219220045
Labeler code 21922
Product ID 21922-045_6ffc01fa-3cf5-4e6c-9760-7ff9873c82df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form SUSPENSION
Route RECTAL
Labeler Encube Ethicals, Inc.
Application ANDA216941
Marketing category ANDA
Marketing start 2023-06-01
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 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 A216941-001 MESALAMINE MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216941-001 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 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216941-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2023-05-30 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 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21922-045-01 Mesalamine 60 mL in 1 BOTTLE, DISPENSING SUSPENSION 60 6 21922-045-47 Mesalamine 7 in 1 CARTON SUSPENSION 7 6 21922-045-49 Mesalamine 28 in 1 CARTON SUSPENSION 28 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-045 MESALAMINE SUSPENSION [ENCUBE ETHICALS PRIVATE LIMITED] 4 Current NDC, 3 package rows 20240808_d6b68275-b2a4-4965-9862-cf14acf8c599.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 Units Marketing start Sample Exclude flag Status 21922-045-01 21922004501 60 mL in 1 BOTTLE, DISPENSING 60 ml Historical 21922-045-47 21922004547 7 BOTTLE, DISPENSING in 1 CARTON (21922-045-47) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) 2023-06-01 No No Current 21922-045-49 21922004549 28 BOTTLE, DISPENSING in 1 CARTON (21922-045-49) / 60 mL in 1 BOTTLE, DISPENSING (21922-045-01) 2023-06-01 No No Current