Sulfasalazine

Product NDC
71610-706
11-digit product format
716100706
Labeler code
71610
Product ID
71610-706_a5313f88-2d90-4f75-afb8-9dde2a069fa7
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
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
71610-706-70Sulfasalazine120 in 1 BOTTLETABLET1201
71610-706-80Sulfasalazine180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-706-70EA - Each71610-706df53eb3f-15f4-4dc0-ad93-6a12b346aa9a12023-07-06
71610-706-80EA - Each71610-70620949022-fe68-4912-bc20-649591ee14a012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-706SULFASALAZINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 2 package rows20230517_bf5137fe-60ed-4497-8521-eeb0a684fabf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
71610-706-7071610070670120 TABLET in 1 BOTTLE (71610-706-70) 120 tablet2023-05-16NoNoHistorical
71610-706-8071610070680180 TABLET in 1 BOTTLE (71610-706-80) 180 tablet2023-05-16NoNoHistorical