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 ID: 0013-0101_14feec56-0272-44f5-9315-6a496e19d251
• NDC: 0013-0101
• Product Type: Human Prescription Drug
• Proprietary Name: Azulfidine
• Generic Name: Sulfasalazine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1950-06-20
• Marketing Category: NDA / NDA
• Application Number: NDA007073
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: SULFASALAZINE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0013-0101-01

100 TABLET in 1 BOTTLE (0013-0101-01)

• Marketing Start Date: 1950-06-20
• Marketing End Date: 2024-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0013-0101-20 [00013010120]

Azulfidine TABLET

• Marketing Category: NDA
• Application Number: NDA007073
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1950-06-20

NDC 0013-0101-01 [00013010101]

Azulfidine TABLET

• Marketing Category: NDA
• Application Number: NDA007073
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1950-06-20

NDC 0013-0101-11 [00013010111]

Azulfidine TABLET

• Marketing Category: NDA
• Application Number: NDA007073
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1950-06-20
• Marketing End Date: 2014-03-05

NDC 0013-0101-10 [00013010110]

Azulfidine TABLET

• Marketing Category: NDA
• Application Number: NDA007073
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-02-27

NDC 0013-0101-30 [00013010130]

Azulfidine TABLET

• Marketing Category: NDA
• Application Number: NDA007073
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-02-27

Drug Details

Active Ingredients

Ingredient	Strength
SULFASALAZINE	500 mg/1

OpenFDA Data

• SPL SET ID: ddbe69f3-bd55-45f3-a64f-f60226c744c4
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 3XC8GUZ6CB
• 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"

NDC	Brand Name	Generic Name
0013-0101	Azulfidine	Sulfasalazine
0013-0102	Azulfidine	Sulfasalazine
0093-3234	Sulfasalazine	Sulfasalazine
0591-0796	Sulfasalazine	Sulfasalazine
0603-5801	Sulfasalazine	sulfasalazine
10544-288	Sulfasalazine	sulfasalazine
23155-019	Sulfasalazine	Sulfasalazine
33261-756	Sulfasalazine	sulfasalazine
43353-495	Sulfasalazine	Sulfasalazine
50090-0086	Sulfasalazine	Sulfasalazine
50090-2013	Sulfasalazine	Sulfasalazine
50268-730	Sulfasalazine	Sulfasalazine
59762-0104	Sulfasalazine	Sulfasalazine