FDA.reportPublic FDA data

Sulfasalazine

Product NDC
33261-756
11-digit product format
332610756
Labeler code
33261
Product ID
33261-756_5a387e4b-9fde-43fa-bd07-ac2a369147ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040349
Marketing category
ANDA
Marketing start
2002-01-11
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
2019-12-31
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
33261-756-002020-01-31C16284748780-19d75b9d0-76cc-f424-e053-dadaa90a57ceSULFASALAZINE TABLETS, USP
33261-756-952020-01-31C16284748780-19d75b9d0-76cc-f424-e053-dadaa90a57ceSULFASALAZINE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-756-00Sulfasalazine100 in 1 BOTTLE, PLASTICTABLET1001
33261-756-95Sulfasalazine125 in 1 BOTTLE, PLASTICTABLET1251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-756-00EA - Each33261-75684ed3887-f78c-4df9-a1d3-8d87fe25b2d112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1USULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-756SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140213_2fc8c918-157c-4898-9b26-80d9ae2fc143.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN2fc8c918-157c-4898-9b26-80d9ae2fc1431
198232sulfasalazine 500 MG Oral TabletSCD2fc8c918-157c-4898-9b26-80d9ae2fc1431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-756-0033261075600100 in 1 BOTTLE, PLASTICHistorical
33261-756-9533261075695125 in 1 BOTTLE, PLASTICHistorical