Balsalazide Disodium

Product NDC
50268-102
11-digit product format
502680102
Labeler code
50268
Product ID
50268-102_472f9b42-99d2-a541-e063-6294a90a8926
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Balsalazide Disodium
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA077883
Marketing category
ANDA
Marketing start
2014-11-06
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
50268-102-11Balsalazide Disodium1 in 1 BLISTER PACKCAPSULE110
50268-102-13Balsalazide Disodium30 in 1 BOXCAPSULE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-102-11EA - Each50268-1026adac851-4530-48ff-b726-2511a92227b912015-02-02
50268-102-13EA - Each50268-102737fcdd1-4fdf-4b74-bea4-e92304ce2d3a12015-02-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-102BALSALAZIDE DISODIUM CAPSULE [AVPAK]9Current NDC, Legacy NDC, 2 package rows20240124_509b83b6-cde6-393b-8560-557793b6a529.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
50268-102-11502680102111 in 1 BLISTER PACKHistorical
50268-102-135026801021330 BLISTER PACK in 1 BOX (50268-102-13) / 1 CAPSULE in 1 BLISTER PACK (50268-102-11) 30 blister pack2014-11-060000-00-00NoNoCurrent