NDC 43353-495

Sulfasalazine

Sulfasalazine

Sulfasalazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Sulfasalazine.

Product ID43353-495_1572fb98-18b9-45d9-969c-e2df8fa04f28
NDC43353-495
Product TypeHuman Prescription Drug
Proprietary NameSulfasalazine
Generic NameSulfasalazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-07-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA007073
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameSULFASALAZINE
Active Ingredient Strength500 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-495-53

60 TABLET in 1 BOTTLE, PLASTIC (43353-495-53)
Marketing Start Date2009-05-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-495-80 [43353049580]

Sulfasalazine TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA007073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-29

NDC 43353-495-70 [43353049570]

Sulfasalazine TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA007073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-29

NDC 43353-495-53 [43353049553]

Sulfasalazine TABLET
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA007073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-29

Drug Details

Active Ingredients

IngredientStrength
SULFASALAZINE500 mg/1

OpenFDA Data

SPL SET ID:a5a23c68-f5bd-42dd-b72c-0641659bae46
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198232
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    NDC Crossover Matching brand name "Sulfasalazine" or generic name "Sulfasalazine"

    NDCBrand NameGeneric Name
    0093-3234SulfasalazineSulfasalazine
    0591-0796SulfasalazineSulfasalazine
    0603-5801Sulfasalazinesulfasalazine
    10544-288Sulfasalazinesulfasalazine
    23155-019SulfasalazineSulfasalazine
    33261-756Sulfasalazinesulfasalazine
    43353-495SulfasalazineSulfasalazine
    50090-0086SulfasalazineSulfasalazine
    50090-2013SulfasalazineSulfasalazine
    50268-730SulfasalazineSulfasalazine
    59762-0104SulfasalazineSulfasalazine
    68071-4215SulfasalazineSulfasalazine
    68788-9021SULFASALAZINESULFASALAZINE
    70518-0185SulfasalazineSulfasalazine
    70518-1829SulfasalazineSulfasalazine
    59762-5000SulfasalazineSulfasalazine
    63629-5688SulfasalazineSulfasalazine
    70518-2342SulfasalazineSulfasalazine
    0013-0101AzulfidineSulfasalazine
    0013-0102AzulfidineSulfasalazine

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.