FDA.reportPublic FDA data

Dipentum

Product NDC
0037-6860
11-digit product format
000376860
Labeler code
0037
Product ID
0037-6860_9a4c3abc-74c9-4a2c-a8e3-fc0100d873d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olsalazine sodium
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA019715
Marketing category
NDA
Marketing start
2015-05-15
Substance
OLSALAZINE SODIUM
Active strength
250 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLSALAZINE SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY7JEW0XG7I
Rxcui905162, 905164

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6caced09-10d9-0a78-cc7d-35b444e1642bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0037-6860-10Dipentum100 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-6860-10EA - Each0037-686015c44237-9463-40ed-af62-9799cdc80f7712015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLSALAZINE SODIUMACTIVE INGREDIENTY7JEW0XG7IDIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS]1
OLSALAZINEACTIVE MOIETYULS5I8J03ODIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RDIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LDIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-6860DIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 1 package rows20240830_8512d0c6-db4e-4673-b3b4-28975c18413f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905164Dipentum 250 MG Oral CapsulePSN8512d0c6-db4e-4673-b3b4-28975c18413f15
905162olsalazine sodium 250 MG Oral CapsulePSN8512d0c6-db4e-4673-b3b4-28975c18413f15
905164olsalazine sodium 250 MG Oral Capsule [Dipentum]SBD8512d0c6-db4e-4673-b3b4-28975c18413f15
905162olsalazine sodium 250 MG Oral CapsuleSCD8512d0c6-db4e-4673-b3b4-28975c18413f15
905164Dipentum 250 MG Oral CapsuleSY8512d0c6-db4e-4673-b3b4-28975c18413f15
905164Dipentum 250 MG Oral CapsulePSN9dd522a3-587e-44ab-9de3-a0fd079f2ffb3
905162olsalazine sodium 250 MG Oral CapsulePSN9dd522a3-587e-44ab-9de3-a0fd079f2ffb3
905164olsalazine sodium 250 MG Oral Capsule [Dipentum]SBD9dd522a3-587e-44ab-9de3-a0fd079f2ffb3
905162olsalazine sodium 250 MG Oral CapsuleSCD9dd522a3-587e-44ab-9de3-a0fd079f2ffb3
905164Dipentum 250 MG Oral CapsuleSY9dd522a3-587e-44ab-9de3-a0fd079f2ffb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0037-6860-1000037686010100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10) 2015-05-150000-00-00NoNoCurrent