NDC 45043-001

Cholbam

Cholic Acid

Cholbam is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Manchester Pharmaceuticals, Llc. The primary component is Cholic Acid.

Product ID45043-001_83e385b7-54bc-4ee2-b477-4e7524508ee3
NDC45043-001
Product TypeHuman Prescription Drug
Proprietary NameCholbam
Generic NameCholic Acid
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-03-31
Marketing CategoryNDA / NDA
Application NumberNDA205750
Labeler NameManchester Pharmaceuticals, LLC
Substance NameCHOLIC ACID
Active Ingredient Strength50 mg/1
Pharm ClassesBile Acid [EPC], Bile Acids and Salts [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 45043-001-02

90 CAPSULE in 1 BOTTLE (45043-001-02)
Marketing Start Date2015-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45043-001-02 [45043000102]

Cholbam CAPSULE
Marketing CategoryNDA
Application NumberNDA205750
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-31

Drug Details

Active Ingredients

IngredientStrength
CHOLIC ACID50 mg/1

OpenFDA Data

SPL SET ID:e5b67402-8550-4604-97a0-c7b149fbf753
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1440868
  • 1440861
  • 1608274
  • 1608276
  • Pharmacological Class

    • Bile Acid [EPC]
    • Bile Acids and Salts [CS]

    NDC Crossover Matching brand name "Cholbam" or generic name "Cholic Acid"

    NDCBrand NameGeneric Name
    45043-001CholbamCholic Acid
    45043-002CholbamCholic Acid

    Trademark Results [Cholbam]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CHOLBAM
    CHOLBAM
    85884088 4752361 Live/Registered
    RETROPHIN, INC.
    2013-03-22

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