Balsalazide Disodium

Product NDC
72162-2095
11-digit product format
721622095
Labeler code
72162
Product ID
72162-2095_fa1fdea0-35a4-46c7-ada0-3f5c71955075
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Balsalazide Disodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
72162-2095-2Balsalazide Disodium280 in 1 BOTTLECAPSULE280102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2095-2EA - Each72162-209594627682-5064-4d0a-8866-db7270c38fc412023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2095BALSALAZIDE DISODIUM CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20250406_cd73c9f1-d83b-4206-b2c6-1bd111e11263.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2095-272162209502280 CAPSULE in 1 BOTTLE (72162-2095-2) 280 capsule2007-12-28NoNoHistorical