Colazal

Product NDC
65649-101
11-digit product format
656490101
Labeler code
65649
Product ID
65649-101_c3a79ded-1d64-4ce2-b55d-f8bd077fdf2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
balsalazide disodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Salix Pharmaceuticals, Inc
Application
NDA020610
Marketing category
NDA
Marketing start
2000-07-18
Marketing end
0000-00-00
Substance
BALSALAZIDE DISODIUM
Active strength
750 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65649-101-02EA - Each65649-1010e8f9c7b-015b-4683-bc2e-93b069beb3f712012-07-24
65649-101-50EA - Each65649-1012276a609-e98c-4a82-bf97-c4889f640cf012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BALSALAZIDE DISODIUMACTIVE INGREDIENT1XL6BJI034COLAZAL (BALSALAZIDE DISODIUM) CAPSULE [SALIX PHARMACEUTICALS, INC.]11
BALSALAZIDEACTIVE MOIETYP80AL8J7ZPCOLAZAL (BALSALAZIDE DISODIUM) CAPSULE [SALIX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLAZAL (BALSALAZIDE DISODIUM) CAPSULE [SALIX PHARMACEUTICALS, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLAZAL (BALSALAZIDE DISODIUM) CAPSULE [SALIX PHARMACEUTICALS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65649-101COLAZAL (BALSALAZIDE DISODIUM) CAPSULE [SALIX PHARMACEUTICALS, INC]28Legacy NDC20250411_22f41e83-b9fb-4c9e-8cc3-f457034191a8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65649-101-0265649010102280 CAPSULE in 1 BOTTLE (65649-101-02) 280 capsule2000-07-180000-00-00NoNoCurrent