NDC 68071-4215

Sulfasalazine

Sulfasalazine

Sulfasalazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Sulfasalazine.

Product ID68071-4215_62101b84-df0c-7996-e053-2a91aa0a6376
NDC68071-4215
Product TypeHuman Prescription Drug
Proprietary NameSulfasalazine
Generic NameSulfasalazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1982-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA085828
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameSULFASALAZINE
Active Ingredient Strength500 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-4215-1

100 TABLET in 1 BOTTLE (68071-4215-1)
Marketing Start Date2018-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4215-1 [68071421501]

Sulfasalazine TABLET
Marketing CategoryANDA
Application NumberANDA085828
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-05

Drug Details

Active Ingredients

IngredientStrength
SULFASALAZINE500 mg/1

OpenFDA Data

SPL SET ID:62101b84-df0b-7996-e053-2a91aa0a6376
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198232
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]
    • 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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