FDA.reportPublic FDA data

Sulfasalazine

Product NDC
59762-0104
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

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
Rxcui313142

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-0104-159762010401100 TABLET, DELAYED RELEASE in 1 BOTTLE (59762-0104-1) 2005-05-052024-11-30NoNoCurrent
59762-0104-259762010402300 TABLET, DELAYED RELEASE in 1 BOTTLE (59762-0104-2) 2005-05-050000-00-00NoNoCurrent
59762-0104-5597620104051 BOTTLE in 1 CARTON (59762-0104-5) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-03-230000-00-00NoNoCurrent
59762-0104-6597620104061 BOTTLE in 1 CARTON (59762-0104-6) / 300 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-04-060000-00-00NoNoCurrent