FDA.reportPublic FDA data

Sulfasalazine

Product NDC
70518-1829
11-digit product format
705181829
Labeler code
70518
Product ID
70518-1829_4976ef9d-bb2f-1498-e063-6294a90a81d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA007073
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-01-28
Substance
SULFASALAZINE
Active strength
500 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfasalazine
Listing expiration
2027-12-31

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
70518-1829-0Sulfasalazine270 in 1 BOTTLE, PLASTICTABLET27015
70518-1829-1Sulfasalazine30 in 1 BLISTER PACKTABLET3015
70518-1829-2Sulfasalazine30 in 1 BLISTER PACKTABLET3015
70518-1829-3Sulfasalazine30 in 1 BLISTER PACKTABLET3015
70518-1829-4Sulfasalazine270 in 1 BOTTLE, PLASTICTABLET27015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1829SULFASALAZINE TABLET [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 5 package rows20250509_88441a9f-b4f9-455d-a355-46fb30699a7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN88441a9f-b4f9-455d-a355-46fb30699a7b15
198232sulfasalazine 500 MG Oral TabletSCD88441a9f-b4f9-455d-a355-46fb30699a7b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1829-070518182900270 TABLET in 1 BOTTLE, PLASTIC (70518-1829-0) 270 tablet2019-01-280000-00-00NoNoCurrent
70518-1829-17051818290130 TABLET in 1 BLISTER PACK (70518-1829-1) 30 tablet2020-03-300000-00-00NoNoCurrent
70518-1829-27051818290230 TABLET in 1 BLISTER PACK (70518-1829-2) 30 tablet2020-08-200000-00-00NoNoCurrent
70518-1829-37051818290330 TABLET in 1 BLISTER PACK (70518-1829-3) 30 tablet2021-10-290000-00-00NoNoCurrent
70518-1829-470518182904270 in 1 BOTTLE, PLASTICHistorical