NDC 0013-0102

Azulfidine EN-tabs

Sulfasalazine

Azulfidine EN-tabs is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Pharmacia & Upjohn Company Llc. The primary component is Sulfasalazine.

• Product ID: 0013-0102_0802bf55-2d66-4211-8974-2884c70011b2
• NDC: 0013-0102
• Product Type: Human Prescription Drug
• Proprietary Name: Azulfidine EN-tabs
• Generic Name: Sulfasalazine
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 1950-06-20
• Marketing Category: NDA / NDA
• Application Number: NDA007073
• Labeler Name: Pharmacia & Upjohn Company LLC
• 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 0013-0102-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE (0013-0102-01)

• Marketing Start Date: 1950-06-20
• Marketing End Date: 2024-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0013-0102-20 [00013010220]

Azulfidine EN-tabs TABLET, DELAYED RELEASE

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

NDC 0013-0102-01 [00013010201]

Azulfidine EN-tabs TABLET, DELAYED RELEASE

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

Drug Details

Active Ingredients

Ingredient	Strength
SULFASALAZINE	500 mg/1

OpenFDA Data

• SPL SET ID: b9ef541a-93c8-4428-ba45-398aa0b327d1
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 3XC8GUZ6CB
• RxNorm Concept Unique ID - RxCUI:
  • 313142
  • 724154

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

NDC Crossover Matching brand name "Azulfidine EN-tabs" 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