Sulfasalazine

Product NDC
63629-9715
11-digit product format
636299715
Labeler code
63629
Product ID
63629-9715_00104d3b-3b62-49fb-8a04-26ec7c24efcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfasalazine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA085828
Marketing category
ANDA
Marketing start
2022-12-15
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
63629-9715-1Sulfasalazine90 in 1 BOTTLE, PLASTICTABLET90101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9715SULFASALAZINE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240509_618c5324-d0a6-4d00-9b12-0de88a71c180.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198232sulfaSALAzine 500 MG Oral TabletPSN618c5324-d0a6-4d00-9b12-0de88a71c180101
198232sulfasalazine 500 MG Oral TabletSCD618c5324-d0a6-4d00-9b12-0de88a71c180101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-9715-16362997150190 TABLET in 1 BOTTLE, PLASTIC (63629-9715-1) 90 tablet2023-06-22NoNoCurrent