NDC 0013-0101

Azulfidine

Sulfasalazine

Azulfidine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Sulfasalazine.

Product ID0013-0101_14feec56-0272-44f5-9315-6a496e19d251
NDC0013-0101
Product TypeHuman Prescription Drug
Proprietary NameAzulfidine
Generic NameSulfasalazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1950-06-20
Marketing CategoryNDA / NDA
Application NumberNDA007073
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameSULFASALAZINE
Active Ingredient Strength500 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0013-0101-01

100 TABLET in 1 BOTTLE (0013-0101-01)
Marketing Start Date1950-06-20
Marketing End Date2024-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0013-0101-20 [00013010120]

Azulfidine TABLET
Marketing CategoryNDA
Application NumberNDA007073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1950-06-20

NDC 0013-0101-01 [00013010101]

Azulfidine TABLET
Marketing CategoryNDA
Application NumberNDA007073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1950-06-20

NDC 0013-0101-11 [00013010111]

Azulfidine TABLET
Marketing CategoryNDA
Application NumberNDA007073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1950-06-20
Marketing End Date2014-03-05

NDC 0013-0101-10 [00013010110]

Azulfidine TABLET
Marketing CategoryNDA
Application NumberNDA007073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-27

NDC 0013-0101-30 [00013010130]

Azulfidine TABLET
Marketing CategoryNDA
Application NumberNDA007073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-27

Drug Details

Active Ingredients

IngredientStrength
SULFASALAZINE500 mg/1

OpenFDA Data

SPL SET ID:ddbe69f3-bd55-45f3-a64f-f60226c744c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198232
  • 208437
  • UPC Code
  • 0300130101012
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

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

    NDCBrand NameGeneric Name
    0013-0101AzulfidineSulfasalazine
    0013-0102AzulfidineSulfasalazine
    0093-3234SulfasalazineSulfasalazine
    0591-0796SulfasalazineSulfasalazine
    0603-5801Sulfasalazinesulfasalazine
    10544-288Sulfasalazinesulfasalazine
    23155-019SulfasalazineSulfasalazine
    33261-756Sulfasalazinesulfasalazine
    43353-495SulfasalazineSulfasalazine
    50090-0086SulfasalazineSulfasalazine
    50090-2013SulfasalazineSulfasalazine
    50268-730SulfasalazineSulfasalazine
    59762-0104SulfasalazineSulfasalazine

    Trademark Results [Azulfidine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AZULFIDINE
    AZULFIDINE
    72071688 0689772 Live/Registered
    PHARMACIA LABORATORIES, INC.
    1959-04-16

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