Sulfasalazine

Product NDC
50090-0086
11-digit product format
500900086
Labeler code
50090
Product ID
50090-0086_48066ade-48d8-492d-b0b6-9aafad705a5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0086-0Sulfasalazine50 in 1 BOTTLETABLET5020
50090-0086-3Sulfasalazine30 in 1 BOTTLETABLET3020
50090-0086-4Sulfasalazine90 in 1 BOTTLETABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0086-4EA - Each50090-00862da5a1b1-459d-4f30-9cc3-e05a902a535d12023-08-08

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0086SULFASALAZINE TABLET [A-S MEDICATION SOLUTIONS]20Current NDC, Legacy NDC, 3 package rows20250417_32fd1726-ed81-4441-9594-3aecf2db1dbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN32fd1726-ed81-4441-9594-3aecf2db1dbf20
198232sulfasalazine 500 MG Oral TabletSCD32fd1726-ed81-4441-9594-3aecf2db1dbf20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0086-05009000860050 TABLET in 1 BOTTLE (50090-0086-0) 50 tablet2018-11-280000-00-00NoNoCurrent
50090-0086-35009000860330 TABLET in 1 BOTTLE (50090-0086-3) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0086-45009000860490 TABLET in 1 BOTTLE (50090-0086-4) 90 tablet2021-11-100000-00-00NoNoCurrent