NDC 0603-5801

Sulfasalazine

Sulfasalazine

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

• Product ID: 0603-5801_6706375c-9731-4dc7-b777-1459079a6419
• NDC: 0603-5801
• Product Type: Human Prescription Drug
• Proprietary Name: Sulfasalazine
• Generic Name: Sulfasalazine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2002-01-11
• Marketing End Date: 2019-07-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040349
• Labeler Name: Par Pharmaceutical
• Substance Name: SULFASALAZINE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N

Packaging

NDC 0603-5801-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-5801-21)

• Marketing Start Date: 2002-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0603-5801-04 [00603580104]

Sulfasalazine TABLET

• Marketing Category: ANDA
• Application Number: ANDA040349
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-01-11
• Marketing End Date: 2019-07-31

NDC 0603-5801-32 [00603580132]

Sulfasalazine TABLET

• Marketing Category: ANDA
• Application Number: ANDA040349
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-01-11
• Marketing End Date: 2019-07-31

NDC 0603-5801-28 [00603580128]

Sulfasalazine TABLET

• Marketing Category: ANDA
• Application Number: ANDA040349
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-01-11
• Marketing End Date: 2019-07-31

NDC 0603-5801-21 [00603580121]

Sulfasalazine TABLET

• Marketing Category: ANDA
• Application Number: ANDA040349
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-01-11
• Marketing End Date: 2019-07-31

Drug Details

Active Ingredients

Ingredient	Strength
SULFASALAZINE	500 mg/1

OpenFDA Data

• SPL SET ID: 3f915e6f-aa04-4ba6-8553-d443fb177d6d
• Manufacturer:
  • Par Pharmaceutical
• UNII:
  • 3XC8GUZ6CB
• RxNorm Concept Unique ID - RxCUI:
  • 198232
• UPC Code:
  • 0306035801217

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

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

NDC	Brand Name	Generic Name
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
68071-4215	Sulfasalazine	Sulfasalazine
68788-9021	SULFASALAZINE	SULFASALAZINE
70518-0185	Sulfasalazine	Sulfasalazine
70518-1829	Sulfasalazine	Sulfasalazine
59762-5000	Sulfasalazine	Sulfasalazine
63629-5688	Sulfasalazine	Sulfasalazine
70518-2342	Sulfasalazine	Sulfasalazine
0013-0101	Azulfidine	Sulfasalazine
0013-0102	Azulfidine	Sulfasalazine