Home NDC 58914-501 Canasa
Product NDC 58914-501
11-digit product format 589140501
Labeler code 58914
Product ID 58914-501_1b5b916a-214b-4fb9-bca1-407b8107071f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form SUPPOSITORY
Route RECTAL
Labeler Allergan, Inc.
Application NDA021252
Marketing category NDA
Marketing start 2001-01-05
Substance MESALAMINE
Active strength 1000 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 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021252-001 CANASA 500MG SUPPOSITORY / RECTAL 2001-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021252-002 CANASA 1GM SUPPOSITORY / RECTAL AB RLD, RS 2004-11-05 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021252-002 8217083 2028-06-06 Drug product 2013-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021252-002 8436051 2028-06-06 Drug product 2013-05-24 caaa826d4ba7…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…
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Canasa
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESALAMINE 1000 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58914-501-33 Canasa 3 in 1 BOX SUPPOSITORY 3 30 58914-501-42 Canasa 42 in 1 BOX SUPPOSITORY 42 30 58914-501-56 Canasa 30 in 1 BOX SUPPOSITORY 30 30
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58914-501 CANASA (MESALAMINE) SUPPOSITORY [ALLERGAN, INC.] 28 Current NDC, Legacy NDC, 3 package rows 20241211_89d91601-152b-4398-bebe-af1c023e9935.zip
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 58914-501-33 58914050133 3 SUPPOSITORY in 1 BOX (58914-501-33) 3 suppository 2001-01-05 0000-00-00 Yes No Current 58914-501-42 58914050142 42 SUPPOSITORY in 1 BOX (58914-501-42) 42 suppository 2001-01-05 0000-00-00 No No Current 58914-501-56 58914050156 30 SUPPOSITORY in 1 BOX (58914-501-56) 30 suppository 2001-01-05 0000-00-00 No No Current