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 ID68151-0312_75c040b8-d3c3-4df8-adb9-af948f9bc0dd
NDC68151-0312
Product TypeHuman Prescription Drug
Proprietary NameDipentum
Generic NameOlsalazine Sodium
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2015-05-15
Marketing CategoryNDA / NDA
Application NumberNDA019715
Labeler NameCarilion Materials Management
Substance NameOLSALAZINE SODIUM
Active Ingredient Strength250 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68151-0312-1

1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68151-0312-1)
Marketing Start Date2017-12-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-0312-1 [68151031201]

Dipentum CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA019715
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OLSALAZINE SODIUM250 mg/1

OpenFDA Data

SPL SET ID:9dd522a3-587e-44ab-9de3-a0fd079f2ffb
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0037-6860Dipentumolsalazine sodium
    68151-0312Dipentumolsalazine sodium
    68151-3120Dipentumolsalazine sodium

    Trademark Results [Dipentum]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIPENTUM
    DIPENTUM
    76481658 not registered Dead/Abandoned
    Celltech Pharmaceuticals, Inc.
    2003-01-13
    DIPENTUM
    DIPENTUM
    76481657 not registered Dead/Abandoned
    Celltech Pharmaceuticals, Inc.
    2003-01-13
    DIPENTUM
    DIPENTUM
    73506342 1337522 Live/Registered
    Pharmacia, Inc.
    1984-10-30

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