NDC 50090-4371

Colesevelam HCL

Colesevelam Hcl

Colesevelam HCL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Colesevelam Hydrochloride.

• Product ID: 50090-4371_16c35e4b-b078-4700-adad-b83a6d5f3d27
• NDC: 50090-4371
• Product Type: Human Prescription Drug
• Proprietary Name: Colesevelam HCL
• Generic Name: Colesevelam Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209038
• Labeler Name: A-S Medication Solutions
• Substance Name: COLESEVELAM HYDROCHLORIDE
• Active Ingredient Strength: 625 mg/1
• Pharm Classes: Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50090-4371-0

90 TABLET, FILM COATED in 1 BOTTLE (50090-4371-0)

• Marketing Start Date: 2019-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-4371-0 [50090437100]

Colesevelam HCL TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209038
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-06-20

Drug Details

Active Ingredients

Ingredient	Strength
COLESEVELAM HYDROCHLORIDE	625 mg/1

OpenFDA Data

• SPL SET ID: 5eb26657-09cf-4229-a567-1395b58bba6b
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • P4SG24WI5Q
• RxNorm Concept Unique ID - RxCUI:
  • 866910

Pharmacological Class

• Bile Acid Sequestrant [EPC]
• Bile-acid Binding Activity [MoA]
• Bile Acid Sequestrant [EPC]
• Bile-acid Binding Activity [MoA]

NDC Crossover Matching brand name "Colesevelam HCL" or generic name "Colesevelam Hcl"

NDC	Brand Name	Generic Name
50090-4371	Colesevelam HCL	Colesevelam HCL
63629-8767	Colesevelam HCL	Colesevelam HCL
67877-506	Colesevelam HCL	Colesevelam HCL