NDC 68151-0312

Dipentum

Olsalazine Sodium

Dipentum is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Olsalazine Sodium.

• Product ID: 68151-0312_75c040b8-d3c3-4df8-adb9-af948f9bc0dd
• NDC: 68151-0312
• Product Type: Human Prescription Drug
• Proprietary Name: Dipentum
• Generic Name: Olsalazine Sodium
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2015-05-15
• Marketing Category: NDA / NDA
• Application Number: NDA019715
• Labeler Name: Carilion Materials Management
• Substance Name: OLSALAZINE SODIUM
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 68151-0312-1

1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68151-0312-1)

• Marketing Start Date: 2017-12-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68151-0312-1 [68151031201]

Dipentum CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA019715
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-26
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
OLSALAZINE SODIUM	250 mg/1

OpenFDA Data

• SPL SET ID: 9dd522a3-587e-44ab-9de3-a0fd079f2ffb
• Manufacturer:
  • Carilion Materials Management
• UNII:
  • Y7JEW0XG7I
• RxNorm Concept Unique ID - RxCUI:
  • 905164
  • 905162

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

NDC Crossover Matching brand name "Dipentum" or generic name "Olsalazine Sodium"

NDC	Brand Name	Generic Name
0037-6860	Dipentum	olsalazine sodium
68151-0312	Dipentum	olsalazine sodium
68151-3120	Dipentum	olsalazine sodium