FDA.reportPublic FDA data

Sulfasalazine

Product NDC
59762-5000
11-digit product format
597625000
Labeler code
59762
Product ID
59762-5000_7f481885-e195-4b1d-8fe3-27cc14ed59a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA007073
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-07-01
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

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 Identifiers#

Field, Values table
FieldValues
Unii3XC8GUZ6CB
Rxcui198232

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
59762-5000-1Sulfasalazine100 in 1 BOTTLETABLET10026
59762-5000-2Sulfasalazine300 in 1 BOTTLETABLET30026
59762-5000-5Sulfasalazine1 in 1 CARTONTABLET126
59762-5000-5Sulfasalazine100 in 1 BOTTLETABLET10026
59762-5000-6Sulfasalazine1 in 1 CARTONTABLET126
59762-5000-6Sulfasalazine300 in 1 BOTTLETABLET30026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5000-1EA - Each59762-5000ad13d369-308e-4276-8f03-c2733f0137fe12012-07-24
59762-5000-2EA - Each59762-5000a5a081d5-c0a9-4d71-88c6-328344070a6f12012-07-24
59762-5000-5EA - Each59762-5000ad74d621-2fbb-444f-ae0b-9a01f2a5719b12020-05-08
59762-5000-6EA - Each59762-50008135fb29-9ebc-4492-8cb1-d58c2162405212020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE TABLET [GREENSTONE LLC]10
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE TABLET [GREENSTONE LLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE TABLET [GREENSTONE LLC]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFASALAZINE TABLET [GREENSTONE LLC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SULFASALAZINE TABLET [GREENSTONE LLC]10
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS 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
59762-5000SULFASALAZINE TABLET [GREENSTONE LLC]25Current NDC, Legacy NDC, 6 package rows20250223_48fbc535-a33a-45ee-85ff-9d1ec9b31d9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN48fbc535-a33a-45ee-85ff-9d1ec9b31d9c26
198232sulfasalazine 500 MG Oral TabletSCD48fbc535-a33a-45ee-85ff-9d1ec9b31d9c26
198232sulfaSALAzine 500 MG Oral TabletPSN32fd1726-ed81-4441-9594-3aecf2db1dbf20
198232sulfasalazine 500 MG Oral TabletSCD32fd1726-ed81-4441-9594-3aecf2db1dbf20
198232sulfaSALAzine 500 MG Oral TabletPSN88441a9f-b4f9-455d-a355-46fb30699a7b15
198232sulfasalazine 500 MG Oral TabletSCD88441a9f-b4f9-455d-a355-46fb30699a7b15
198232sulfaSALAzine 500 MG Oral TabletPSN76b532a3-e7ca-4929-8c51-c0f66e0806a83
198232sulfasalazine 500 MG Oral TabletSCD76b532a3-e7ca-4929-8c51-c0f66e0806a83
198232sulfaSALAzine 500 MG Oral TabletPSNa5a23c68-f5bd-42dd-b72c-0641659bae462
198232sulfasalazine 500 MG Oral TabletSCDa5a23c68-f5bd-42dd-b72c-0641659bae462
198232sulfaSALAzine 500 MG Oral TabletPSNbf5137fe-60ed-4497-8521-eeb0a684fabf1
198232sulfasalazine 500 MG Oral TabletSCDbf5137fe-60ed-4497-8521-eeb0a684fabf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-5000-159762500001100 TABLET in 1 BOTTLE (59762-5000-1) 100 tablet2003-07-012024-11-30NoNoCurrent
59762-5000-259762500002300 TABLET in 1 BOTTLE (59762-5000-2) 300 tablet2016-05-262024-10-31NoNoCurrent
59762-5000-5597625000051 BOTTLE in 1 CARTON (59762-5000-5) / 100 TABLET in 1 BOTTLE1 bottle2020-04-130000-00-00NoNoCurrent
59762-5000-6597625000061 BOTTLE in 1 CARTON (59762-5000-6) / 300 TABLET in 1 BOTTLE1 bottle2020-04-130000-00-00NoNoCurrent