Home NDC 65084-474 Canasa
Product NDC 65084-474
11-digit product format 650840474
Labeler code 65084
Product ID 65084-474_f22429d1-5a9e-4286-a856-8104e188e35e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form SUPPOSITORY
Route RECTAL
Labeler Mckesson Rxpak Inc
Application NDA021252
Marketing category NDA
Marketing start 2001-01-05
Marketing end 0000-00-00
Substance MESALAMINE
Active strength 1000 mg/1
Pharmacologic classes Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65084-474-14 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65084-474-14 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 65084-474-14 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 65084-474-14 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 65084-474-14 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 65084-474-14 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 65084-474-14 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 65084-474-14 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65084-474-14 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 65084-474-14 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 65084-474-14 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65084-474-14 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021252-001 CANASA MESALAMINE 500MG SUPPOSITORY / RECTAL 2001-01-05 N021252-002 CANASA MESALAMINE 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021252-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021252-002 8217083 2028-06-06 Drug product 2013-05-24 N021252-002 8436051 2028-06-06 Drug product 2013-05-24
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 782e0a99824c…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021252-001 M-187 2019-09-02 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021252-001 M-187 2019-09-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021252-001 M-187 2019-09-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021252-001 M-187 2019-09-02 ea99ee380514…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Canasa MESALAMINE Allergan, Inc. 89d91601-152b-4398-bebe-af1c023e9935 2024-09-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 021252 application number: NDA021252