Balsalazide Disodium

Product NDC
60505-2575
11-digit product format
605052575
Labeler code
60505
Product ID
60505-2575_18469dde-9cd3-fbc8-40ba-8b17b6a9c07a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Balsalazide Disodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077883
Marketing category
ANDA
Marketing start
2007-12-28
Substance
BALSALAZIDE DISODIUM
Active strength
750 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
Balsalazide Disodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BALSALAZIDE DISODIUM750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1XL6BJI034
Rxcui885857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8e3d9cc4-ed07-08af-508a-5f750e6cdb51Product name320260112
34627c48-41a0-6950-dec1-e0baf87a4e18Product name220150914

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2575-0Balsalazide Disodium10 in 1 BLISTER PACKCAPSULE1014
60505-2575-0Balsalazide Disodium10 in 1 CARTONCAPSULE1014
60505-2575-3Balsalazide Disodium30 in 1 BOTTLECAPSULE3014
60505-2575-4Balsalazide Disodium350 in 1 BOTTLECAPSULE35014
60505-2575-7Balsalazide Disodium280 in 1 BOTTLECAPSULE28014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2575-7EA - Each60505-257567293267-eba4-4f49-b576-fa94e3cfd02a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BALSALAZIDE DISODIUMACTIVE INGREDIENT1XL6BJI034BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
BALSALAZIDEACTIVE MOIETYP80AL8J7ZPBALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XBALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
SHELLACINACTIVE INGREDIENT46N107B71OBALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]4
BALSALAZIDE DISODIUMACTIVE INGREDIENT1XL6BJI034BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
BALSALAZIDEACTIVE MOIETYP80AL8J7ZPBALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XBALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
SHELLACINACTIVE INGREDIENT46N107B71OBALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBALSALAZIDE DISODIUM (BALSALAZIDE DISODIUM) CAPSULE [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2575BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.]14Current NDC, Legacy NDC, 5 package rows20250104_f12ffa32-d14b-e9d9-e957-2ef08b64e8b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885857balsalazide disodium 750 MG Oral CapsulePSNcd73c9f1-d83b-4206-b2c6-1bd111e11263102
885857balsalazide disodium 750 MG Oral CapsuleSCDcd73c9f1-d83b-4206-b2c6-1bd111e11263102
885857balsalazide disodium 750 MG Oral CapsulePSNf12ffa32-d14b-e9d9-e957-2ef08b64e8b414
885857balsalazide disodium 750 MG Oral CapsuleSCDf12ffa32-d14b-e9d9-e957-2ef08b64e8b414
885857balsalazide disodium 750 MG Oral CapsulePSN509b83b6-cde6-393b-8560-557793b6a52910
885857balsalazide disodium 750 MG Oral CapsuleSCD509b83b6-cde6-393b-8560-557793b6a52910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2575-06050525750010 BLISTER PACK in 1 CARTON (60505-2575-0) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2007-12-280000-00-00NoNoCurrent
60505-2575-36050525750330 CAPSULE in 1 BOTTLE (60505-2575-3) 30 capsule2007-12-280000-00-00NoNoCurrent
60505-2575-460505257504350 CAPSULE in 1 BOTTLE (60505-2575-4) 350 capsule2007-12-280000-00-00NoNoCurrent
60505-2575-760505257507280 CAPSULE in 1 BOTTLE (60505-2575-7) 280 capsule2007-12-280000-00-00NoNoCurrent