FDA.reportPublic FDA data

Balsalazide Disodium

Product NDC
0054-0079
11-digit product format
000540079
Labeler code
0054
Product ID
0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Balsalazide Disodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA077806
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
34627c48-41a0-6950-dec1-e0baf87a4e18Product name220150914

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0079-28Balsalazide Disodium280 in 1 BOTTLECAPSULE28012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0079-28EA - Each0054-0079d2bb7c9a-1533-44cd-8e0f-0aaf1ab9e31512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BALSALAZIDE DISODIUMACTIVE INGREDIENT1XL6BJI034BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
BALSALAZIDEACTIVE MOIETYP80AL8J7ZPBALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XBALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
GELATININACTIVE INGREDIENT2G86QN327LBALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
SHELLACINACTIVE INGREDIENT46N107B71OBALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC]5
BALSALAZIDE DISODIUMACTIVE INGREDIENT1XL6BJI034BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
BALSALAZIDEACTIVE MOIETYP80AL8J7ZPBALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XBALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LBALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OBALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0079BALSALAZIDE DISODIUM CAPSULE [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 1 package rows20240507_a0498308-14b2-4456-8e13-795f6fc8ea30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885857balsalazide disodium 750 MG Oral CapsulePSNb3ecc533-dd55-4a2f-84c4-ecd454aae76616
885857balsalazide disodium 750 MG Oral CapsuleSCDb3ecc533-dd55-4a2f-84c4-ecd454aae76616
885857balsalazide disodium 750 MG Oral CapsulePSNa0498308-14b2-4456-8e13-795f6fc8ea3012
885857balsalazide disodium 750 MG Oral CapsuleSCDa0498308-14b2-4456-8e13-795f6fc8ea3012
885857balsalazide disodium 750 MG Oral CapsulePSN029833fa-ec5c-6a39-e063-6294a90aa0634
885857balsalazide disodium 750 MG Oral CapsuleSCD029833fa-ec5c-6a39-e063-6294a90aa0634
885857balsalazide disodium 750 MG Oral CapsulePSN3934dfa6-f2f7-4bdc-94fa-6c17224da61d1
885857balsalazide disodium 750 MG Oral CapsuleSCD3934dfa6-f2f7-4bdc-94fa-6c17224da61d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0079-2800054007928280 CAPSULE in 1 BOTTLE (0054-0079-28) 280 capsule2007-12-280000-00-00NoNoCurrent