Canasa

Product NDC: 58914-501
11-digit product format: 589140501
Labeler code: 58914
Product ID: 58914-501_f6634219-3e94-4856-b896-67c3bd3b168d
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 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021252-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021252-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021252-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021252-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021252-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021252-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021252-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021252-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021252-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021252-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021252-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021252-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021252-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021252-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021252-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021252-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021252-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021252-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021252-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021252-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021252-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021252-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021252-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021252-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021252-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021252-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021252-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021252-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021252-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021252-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021252-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021252-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021252-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021252-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021252-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021252-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021252-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021252-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021252-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021252-002	AB	1	`cb3db0bc1861…`

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	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…`

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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
248420	Internal RxNorm lookup
583257	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89d91601-152b-4398-bebe-af1c023e9935	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3	Product name	3	20260128
37997c2c-8686-b078-51f1-fb15da0c0a1c	Product name	6	20260127
97851e97-0a12-4d74-aaa4-9583fe070304	Product name	2	20250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49	Product name	5	20250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564	Product name	5	20240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3	Product name	1	20230124
a4dbd90c-f616-c999-40d7-60da88952163	Product name	2	20190802
77831c26-5062-ed63-fc15-a07600377b5b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58914-501-18	EA - Each	58914-501	bfbdf612-4445-4e22-8ce2-c76c6bd81982	1	2012-07-24
58914-501-42	EA - Each	58914-501	c54f480e-a035-4eaf-ae8d-e86b6ebfa02a	1	2012-07-24
58914-501-56	EA - Each	58914-501	ea6c39be-160c-4bec-be41-a42e08be0997	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mesalamine	ACTIVE INGREDIENT	4Q81I59GXC	CANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]	9
Mesalamine	ACTIVE MOIETY	4Q81I59GXC	CANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]	9
fat, hard	INACTIVE INGREDIENT	8334LX7S21	CANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]	9
MESALAMINE	ACTIVE INGREDIENT	4Q81I59GXC	CANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]	1
MESALAMINE	ACTIVE MOIETY	4Q81I59GXC	CANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]	1
FAT, HARD	INACTIVE INGREDIENT	8334LX7S21	CANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]	1

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

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 ndc (product): 58914-501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Q81I59GXC	MESALAMINE	89-57-6	MESALAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
583257	Canasa 1000 MG Rectal Suppository	PSN	89d91601-152b-4398-bebe-af1c023e9935	30
248420	mesalamine 1000 MG Rectal Suppository	PSN	89d91601-152b-4398-bebe-af1c023e9935	30
583257	mesalamine 1000 MG Rectal Suppository [Canasa]	SBD	89d91601-152b-4398-bebe-af1c023e9935	30
248420	mesalamine 1000 MG Rectal Suppository	SCD	89d91601-152b-4398-bebe-af1c023e9935	30
583257	Canasa 1000 MG Rectal Suppository	SY	89d91601-152b-4398-bebe-af1c023e9935	30
248420	mesalazine 1000 MG Rectal Suppository	SY	89d91601-152b-4398-bebe-af1c023e9935	30

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