FDA.reportPublic FDA data

Sulfasalazine

Product NDC
0093-3234
11-digit product format
000933234
Labeler code
0093
Product ID
0093-3234_6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA085828
Marketing category
ANDA
Marketing start
2022-12-15
Substance
SULFASALAZINE
Active strength
500 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
A085828-001SULFASALAZINESULFASALAZINE500MGTABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085828-001AB

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
2026-08-01 22:54:322026-06A085828-001SULFASALAZINE500MGTABLET / ORALABApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A085828-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SulfasalazineSULFASALAZINEAmerican Health Packagingd967092f-9685-446b-b7b8-17821e29417b2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085828
application number: ANDA085828
SulfasalazineSULFASALAZINEBryant Ranch Prepack618c5324-d0a6-4d00-9b12-0de88a71c1802024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085828
application number: ANDA085828
SulfasalazineSULFASALAZINETeva Pharmaceuticals USA, Inc.3c59593b-e1a5-47cb-a82b-3e5e492053442023-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085828
application number: ANDA085828
ndc (product): 0093-3234

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfasalazine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFASALAZINE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3XC8GUZ6CBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198232Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c59593b-e1a5-47cb-a82b-3e5e49205344Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4c7fc883-c26b-34ca-837e-8c55868a2f87Product name120140508
56183ade-c831-0ad5-5cd8-c6b0b66bfab0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3234-01Sulfasalazine100 in 1 BOTTLE, PLASTICTABLET1005
0093-3234-05Sulfasalazine500 in 1 BOTTLE, PLASTICTABLET5005
0093-3234-10Sulfasalazine1000 in 1 BOTTLE, PLASTICTABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3234-01EA - Each0093-323495699972-3ee0-4b8e-99ae-d7de67c9d87712023-01-09
0093-3234-05EA - Each0093-3234345e2de5-afd2-4926-825e-d35c401ec6ba12023-03-13
0093-3234-10EA - Each0093-32340b16b1d1-0f71-4e18-9d8c-a7ed36cb936712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3234SULFASALAZINE TABLET [TEVA PHARMACEUTICALS USA, INC.]5Current NDC, Legacy NDC, 3 package rows20230907_3c59593b-e1a5-47cb-a82b-3e5e49205344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN618c5324-d0a6-4d00-9b12-0de88a71c180101
198232sulfasalazine 500 MG Oral TabletSCD618c5324-d0a6-4d00-9b12-0de88a71c180101
198232sulfaSALAzine 500 MG Oral TabletPSN3c59593b-e1a5-47cb-a82b-3e5e492053445
198232sulfasalazine 500 MG Oral TabletSCD3c59593b-e1a5-47cb-a82b-3e5e492053445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3234-0100093323401100 TABLET in 1 BOTTLE, PLASTIC (0093-3234-01) 100 tablet2022-12-150000-00-00NoNoCurrent
0093-3234-0500093323405500 TABLET in 1 BOTTLE, PLASTIC (0093-3234-05) 500 tablet2023-02-27NoNoCurrent
0093-3234-10000933234101000 TABLET in 1 BOTTLE, PLASTIC (0093-3234-10) 1000 tablet2022-12-150000-00-00NoNoCurrent