NDC 63629-5688

Sulfasalazine

Sulfasalazine

Sulfasalazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Sulfasalazine.

Product ID63629-5688_132090c1-191f-4acf-859d-162c5940debd
NDC63629-5688
Product TypeHuman Prescription Drug
Proprietary NameSulfasalazine
Generic NameSulfasalazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1982-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA085828
Labeler NameBryant Ranch Prepack
Substance NameSULFASALAZINE
Active Ingredient Strength500 mg/1
Pharm ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-5688-1

30 TABLET in 1 BOTTLE (63629-5688-1)
Marketing Start Date2020-03-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5688-4 [63629568804]

Sulfasalazine TABLET
Marketing CategoryANDA
Application NumberANDA085828
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-02
Inactivation Date2020-01-31

NDC 63629-5688-3 [63629568803]

Sulfasalazine TABLET
Marketing CategoryANDA
Application NumberANDA085828
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-07
Inactivation Date2020-01-31

NDC 63629-5688-1 [63629568801]

Sulfasalazine TABLET
Marketing CategoryANDA
Application NumberANDA085828
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-07
Inactivation Date2020-01-31

NDC 63629-5688-2 [63629568802]

Sulfasalazine TABLET
Marketing CategoryANDA
Application NumberANDA085828
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-07
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SULFASALAZINE500 mg/1

OpenFDA Data

SPL SET ID:1ac35416-0603-44e3-9199-e0639b4de4f0
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
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