FDA.reportPublic FDA data

Sulfasalazine

Product NDC
59762-0104
Requested package NDC
59762-0104-1
11-digit product format
597620104
Labeler code
59762
Product ID
59762-0104_d2a8dbd7-49db-4839-a5ee-0cbb39ae17ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA007073
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2005-05-05
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

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 packagepackage59762-010459762-0104-1DDiscontinued by firm2026-07-31

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
ndc (package): 59762-0104-1
ndc (product): 59762-0104
ndc11 (package): 59762010401
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

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
313142Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
257cee60-b68f-4c2b-b57d-8e4d73d17e09Available 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
59762-0104-1Sulfasalazine100 in 1 BOTTLETABLET, DELAYED RELEASE10030
59762-0104-2Sulfasalazine300 in 1 BOTTLETABLET, DELAYED RELEASE30030
59762-0104-5Sulfasalazine100 in 1 BOTTLETABLET, DELAYED RELEASE10030
59762-0104-5Sulfasalazine1 in 1 CARTONTABLET, DELAYED RELEASE130
59762-0104-6Sulfasalazine1 in 1 CARTONTABLET, DELAYED RELEASE130
59762-0104-6Sulfasalazine300 in 1 BOTTLETABLET, DELAYED RELEASE30030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0104-1EA - Each59762-0104b88c5c0f-5da1-4b42-bb75-df85995c01e912012-07-24
59762-0104-2EA - Each59762-01043ca916b1-5c80-4709-a9c0-90a23f8b24a312012-07-24
59762-0104-5EA - Each59762-010423eeebd1-724b-40b1-b148-b608113388d512020-04-20
59762-0104-6EA - Each59762-0104b7ca099c-75b4-4894-ab4d-b9606332957712020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
ACETONEINACTIVE INGREDIENT1364PS73AFSULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
ALCOHOLINACTIVE INGREDIENT3K9958V90MSULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
TALCINACTIVE INGREDIENT7SEV7J4R1USULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FSULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0104SULFASALAZINE TABLET, DELAYED RELEASE [GREENSTONE LLC]29Current NDC, Legacy NDC, 6 package rows20250223_257cee60-b68f-4c2b-b57d-8e4d73d17e09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313142sulfaSALAzine 500 MG Delayed Release Oral TabletPSN257cee60-b68f-4c2b-b57d-8e4d73d17e0930
313142sulfasalazine 500 MG Delayed Release Oral TabletSCD257cee60-b68f-4c2b-b57d-8e4d73d17e0930

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0104-159762010401100 TABLET, DELAYED RELEASE in 1 BOTTLE (59762-0104-1) 2005-05-052024-11-30NoNoCurrent