FDA.reportPublic FDA data

balsalazide disodium

Product NDC
80005-126
11-digit product format
800050126
Labeler code
80005
Product ID
80005-126_8bfef633-a30b-4aac-b768-cce1c8e151c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
balsalazide disodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Carnegie Pharmaceuticals, LLC
Application
ANDA219422
Marketing category
ANDA
Marketing start
2025-06-30
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219422-001BALSALAZIDE DISODIUMBALSALAZIDE DISODIUM750MGCAPSULE / ORALAB2025-04-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219422-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219422-001BALSALAZIDE DISODIUM750MGCAPSULE / ORALAB2025-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219422-001BALSALAZIDE DISODIUM750MGCAPSULE / ORALAB2025-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A219422-001BALSALAZIDE DISODIUM750MGCAPSULE / ORALAB2025-04-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219422-001BALSALAZIDE DISODIUM750MGCAPSULE / ORALAB2025-04-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219422-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219422-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219422-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219422-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1XL6BJI034Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
885857Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
620f86cb-b6a2-4af8-a642-925dd8a1c5feAvailable on FDA.report

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
80005-126-25balsalazide disodium280 in 1 BOTTLECAPSULE2801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80005-126-25EA - Each80005-126d03dbfc9-ba42-48c0-b63a-e85776f0d4c712025-08-11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
balsalazide disodiumBALSALAZIDE DISODIUMCarnegie Pharmaceuticals, LLC620f86cb-b6a2-4af8-a642-925dd8a1c5fe2025-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219422
application number: ANDA219422
ndc (product): 80005-126

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885857balsalazide disodium 750 MG Oral CapsulePSN620f86cb-b6a2-4af8-a642-925dd8a1c5fe1
885857balsalazide disodium 750 MG Oral CapsuleSCD620f86cb-b6a2-4af8-a642-925dd8a1c5fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80005-126-2580005012625280 CAPSULE in 1 BOTTLE (80005-126-25) 280 capsule2025-06-30NoNoCurrent