FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Canasa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MESALAMINE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Q81I59GXC
Rxcui248420, 583257

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MesalamineACTIVE INGREDIENT4Q81I59GXCCANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]9
MesalamineACTIVE MOIETY4Q81I59GXCCANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]9
fat, hardINACTIVE INGREDIENT8334LX7S21CANASA (MESALAMINE) SUPPOSITORY [APTALIS PHARMA US INC]9
MESALAMINEACTIVE INGREDIENT4Q81I59GXCCANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
MESALAMINEACTIVE MOIETY4Q81I59GXCCANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
FAT, HARDINACTIVE INGREDIENT8334LX7S21CANASA (MESALAMINE) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1

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