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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
3XC8GUZ6CBSULFASALAZINE599-79-1SULFASALAZINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-9715-16362997150190 TABLET in 1 BOTTLE, PLASTIC (63629-9715-1) 90 tablet2023-06-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sulfasalazine Tablets, USP Rx onlyBryant Ranch Prepack2024-04-04HUMAN PRESCRIPTION DRUG LABEL101