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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021252-001CANASAMESALAMINE500MGSUPPOSITORY / RECTAL2001-01-05
N021252-002CANASAMESALAMINE1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021252-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021252-00282170832028-06-06Drug product2013-05-24
N021252-00284360512028-06-06Drug product2013-05-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05c2088c7a36db…
2026-10-15 13:18:302026-09N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05c2088c7a36db…
2026-09-14 22:38:342026-08N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-0584e616aacf4f…
2026-09-14 22:38:342026-08N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-0584e616aacf4f…
2026-08-18 06:07:402026-07N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021252-001CANASA500MGSUPPOSITORY / RECTAL2001-01-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021252-002CANASA1GMSUPPOSITORY / RECTALABRLD, RS2004-11-054b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N021252-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08N021252-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N021252-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021252-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021252-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021252-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021252-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021252-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021252-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021252-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021252-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021252-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021252-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021252-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021252-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021252-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021252-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021252-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021252-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021252-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021252-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021252-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021252-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021252-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021252-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021252-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021252-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021252-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021252-002AB13a93d1ddd44b…

Observed Orange Book patent history#

Patent history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N021252-00282170832028-06-06Drug product2013-05-24c2088c7a36db…
2026-10-15 13:18:302026-09N021252-00284360512028-06-06Drug product2013-05-24c2088c7a36db…
2026-09-14 22:38:342026-08N021252-00282170832028-06-06Drug product2013-05-2484e616aacf4f…
2026-09-14 22:38:342026-08N021252-00284360512028-06-06Drug product2013-05-2484e616aacf4f…
2026-08-18 06:07:402026-07N021252-00282170832028-06-06Drug product2013-05-24caaa826d4ba7…
2026-08-18 06:07:402026-07N021252-00284360512028-06-06Drug product2013-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021252-00282170832028-06-06Drug product2013-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021252-00284360512028-06-06Drug product2013-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-00282170832028-06-06Drug product2013-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021252-00284360512028-06-06Drug product2013-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021252-00282170832028-06-06Drug product2013-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021252-00284360512028-06-06Drug product2013-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-00282170832028-06-06Drug product2013-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021252-00284360512028-06-06Drug product2013-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-00282170832028-06-06Drug product2013-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021252-00284360512028-06-06Drug product2013-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-00282170832028-06-06Drug product2013-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021252-00284360512028-06-06Drug product2013-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-00282170832028-06-06Drug product2013-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021252-00284360512028-06-06Drug product2013-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-00282170832028-06-06Drug product2013-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021252-00284360512028-06-06Drug product2013-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-00282170832028-06-06Drug product2013-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021252-00284360512028-06-06Drug product2013-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021252-00282170832028-06-06Drug product2013-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021252-00284360512028-06-06Drug product2013-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-00282170832028-06-06Drug product2013-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021252-00284360512028-06-06Drug product2013-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-00282170832028-06-06Drug product2013-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021252-00284360512028-06-06Drug product2013-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-00282170832028-06-06Drug product2013-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021252-00284360512028-06-06Drug product2013-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021252-00282170832028-06-06Drug product2013-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021252-00284360512028-06-06Drug product2013-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-00282170832028-06-06Drug product2013-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021252-00284360512028-06-06Drug product2013-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021252-00282170832028-06-06Drug product2013-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021252-00284360512028-06-06Drug product2013-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021252-00282170832028-06-06Drug product2013-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021252-00284360512028-06-06Drug product2013-05-244b0b4de00fa7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021252-001M-1872019-09-0274a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021252-001M-1872019-09-023f01610625f2…
2019-09-15 20:21 UTC2019-09N021252-001M-1872019-09-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N021252-001M-1872019-09-02ea99ee380514…

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
IngredientStrength
MESALAMINE1000 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3Product name320260128
37997c2c-8686-b078-51f1-fb15da0c0a1cProduct name620260127
97851e97-0a12-4d74-aaa4-9583fe070304Product name220250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49Product name520250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564Product name520240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3Product name120230124
a4dbd90c-f616-c999-40d7-60da88952163Product name220190802
77831c26-5062-ed63-fc15-a07600377b5bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58914-501-33Canasa3 in 1 BOXSUPPOSITORY330
58914-501-42Canasa42 in 1 BOXSUPPOSITORY4230
58914-501-56Canasa30 in 1 BOXSUPPOSITORY3030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58914-501-18EA - Each58914-501bfbdf612-4445-4e22-8ce2-c76c6bd8198212012-07-24
58914-501-42EA - Each58914-501c54f480e-a035-4eaf-ae8d-e86b6ebfa02a12012-07-24
58914-501-56EA - Each58914-501ea6c39be-160c-4bec-be41-a42e08be099712012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58914-501CANASA (MESALAMINE) SUPPOSITORY [ALLERGAN, INC.]28Current NDC, Legacy NDC, 3 package rows20241211_89d91601-152b-4398-bebe-af1c023e9935.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583257Canasa 1000 MG Rectal SuppositoryPSN89d91601-152b-4398-bebe-af1c023e993530
248420mesalamine 1000 MG Rectal SuppositoryPSN89d91601-152b-4398-bebe-af1c023e993530
583257mesalamine 1000 MG Rectal Suppository [Canasa]SBD89d91601-152b-4398-bebe-af1c023e993530
248420mesalamine 1000 MG Rectal SuppositorySCD89d91601-152b-4398-bebe-af1c023e993530
583257Canasa 1000 MG Rectal SuppositorySY89d91601-152b-4398-bebe-af1c023e993530
248420mesalazine 1000 MG Rectal SuppositorySY89d91601-152b-4398-bebe-af1c023e993530

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58914-501-33589140501333 SUPPOSITORY in 1 BOX (58914-501-33) 3 suppository2001-01-050000-00-00YesNoCurrent
58914-501-425891405014242 SUPPOSITORY in 1 BOX (58914-501-42) 42 suppository2001-01-050000-00-00NoNoCurrent
58914-501-565891405015630 SUPPOSITORY in 1 BOX (58914-501-56) 30 suppository2001-01-050000-00-00NoNoCurrent