FDA.reportPublic FDA data

Sulfasalazine

Product NDC
43353-495
Requested package NDC
43353-495-53
11-digit product format
433530495
Labeler code
43353
Product ID
43353-495_1572fb98-18b9-45d9-969c-e2df8fa04f28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA007073
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-07-01
Marketing end
0000-00-00
Substance
SULFASALAZINE
Active strength
500 mg/1
Pharmacologic classes
Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43353-49543353-495-53IInactivated by FDA2026-07-31

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N007073-001AZULFIDINESULFASALAZINE500MGTABLET / ORALABRLD, RS, Approved before 1982
N007073-002AZULFIDINE EN-TABSSULFASALAZINE500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N007073-001AB
N007073-002AB

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 22:54:322026-06N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N007073-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N007073-002AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzulfidineSULFASALAZINEPfizer Laboratories Div Pfizer Incddbe69f3-bd55-45f3-a64f-f60226c744c42026-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
Azulfidine EN-tabsSULFASALAZINEPfizer Laboratories Div Pfizer Incb9ef541a-93c8-4428-ba45-398aa0b327d12026-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEREMEDYREPACK INC.88441a9f-b4f9-455d-a355-46fb30699a7b2026-01-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.257cee60-b68f-4c2b-b57d-8e4d73d17e092025-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.48fbc535-a33a-45ee-85ff-9d1ec9b31d9c2025-05-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEA-S Medication Solutions76b532a3-e7ca-4929-8c51-c0f66e0806a82025-04-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEA-S Medication Solutions32fd1726-ed81-4441-9594-3aecf2db1dbf2025-04-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073
SulfasalazineSULFASALAZINEAphena Pharma Solutions - Tennessee, LLCbf5137fe-60ed-4497-8521-eeb0a684fabf2023-05-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 007073
application number: NDA007073

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-495-532023-01-30C16284748780-1f386c64a-0de9-0266-e053-dadaa90a7c1aSulfasalazine Tablets, USP
43353-495-702023-01-30C16284748780-1f386c64a-0de9-0266-e053-dadaa90a7c1aSulfasalazine Tablets, USP
43353-495-802023-01-30C16284748780-1f386c64a-0de9-0266-e053-dadaa90a7c1aSulfasalazine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-495-53Sulfasalazine60 in 1 BOTTLE, PLASTICTABLET602
43353-495-70Sulfasalazine120 in 1 BOTTLE, PLASTICTABLET1202
43353-495-80Sulfasalazine180 in 1 BOTTLE, PLASTICTABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-495-53EA - Each43353-4951f8dfaf6-6f9a-4d24-89ad-d4e90a6c251912014-10-03
43353-495-70EA - Each43353-495d0741148-8ff8-4ebe-9c16-7ac391abf0db12014-10-03
43353-495-80EA - Each43353-49544c2188a-018c-4bfd-ba08-2ae820c2496e12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-495SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 3 package rows20191221_a5a23c68-f5bd-42dd-b72c-0641659bae46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSNa5a23c68-f5bd-42dd-b72c-0641659bae462
198232sulfasalazine 500 MG Oral TabletSCDa5a23c68-f5bd-42dd-b72c-0641659bae462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-495-534335304955360 TABLET in 1 BOTTLE, PLASTIC (43353-495-53) 60 tablet2009-05-290000-00-00NoNoCurrent