NDC 0037-6860

Dipentum

Olsalazine Sodium

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

• Product ID: 0037-6860_58ba53cb-46d7-409f-950c-e8c404149052
• NDC: 0037-6860
• 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: MEDA Pharmaceuticals
• Substance Name: OLSALAZINE SODIUM
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0037-6860-10

100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)

• Marketing Start Date: 2015-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-6860-10 [00037686010]

Dipentum CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA019715
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-05-15

Drug Details

Active Ingredients

Ingredient	Strength
OLSALAZINE SODIUM	250 mg/1

OpenFDA Data

• SPL SET ID: 8512d0c6-db4e-4673-b3b4-28975c18413f
• Manufacturer:
  • MEDA Pharmaceuticals
• UNII:
  • Y7JEW0XG7I
• RxNorm Concept Unique ID - RxCUI:
  • 905164
  • 905162
• UPC Code:
  • 0300376860100

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