FDA.reportPublic FDA data

Sulfasalazine

Product NDC
43353-495
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

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
43353-495-7043353049570120 TABLET in 1 BOTTLE, PLASTIC (43353-495-70) 120 tablet2009-05-290000-00-00NoNoCurrent
43353-495-8043353049580180 TABLET in 1 BOTTLE, PLASTIC (43353-495-80) 180 tablet2009-05-290000-00-00NoNoCurrent