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 ID: 45043-001_83e385b7-54bc-4ee2-b477-4e7524508ee3
• NDC: 45043-001
• Product Type: Human Prescription Drug
• Proprietary Name: Cholbam
• Generic Name: Cholic Acid
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA205750
• Labeler Name: Manchester Pharmaceuticals, LLC
• Substance Name: CHOLIC ACID
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Bile Acid [EPC], Bile Acids and Salts [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 45043-001-02

90 CAPSULE in 1 BOTTLE (45043-001-02)

• Marketing Start Date: 2015-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45043-001-02 [45043000102]

Cholbam CAPSULE

• Marketing Category: NDA
• Application Number: NDA205750
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-03-31

Drug Details

Active Ingredients

Ingredient	Strength
CHOLIC ACID	50 mg/1

OpenFDA Data

• SPL SET ID: e5b67402-8550-4604-97a0-c7b149fbf753
• Manufacturer:
  • Manchester Pharmaceuticals
• UNII:
  • G1JO7801AE
• 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"

NDC	Brand Name	Generic Name
45043-001	Cholbam	Cholic Acid
45043-002	Cholbam	Cholic Acid