NDC 0115-1320

Colesevelam Hydrochloride

Colesevelam Hydrochloride

Colesevelam Hydrochloride is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Colesevelam Hydrochloride.

Product ID0115-1320_3d4f5b2f-314d-4a7f-b580-0efb31a24812
NDC0115-1320
Product TypeHuman Prescription Drug
Proprietary NameColesevelam Hydrochloride
Generic NameColesevelam Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2018-05-17
Marketing CategoryANDA / ANDA
Application NumberANDA091600
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameCOLESEVELAM HYDROCHLORIDE
Active Ingredient Strength625 mg/1
Pharm ClassesBile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0115-1320-19

180 TABLET, COATED in 1 BOTTLE (0115-1320-19)
Marketing Start Date2018-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1320-19 [00115132019]

Colesevelam Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA091600
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-17

Drug Details

Active Ingredients

IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/1

OpenFDA Data

SPL SET ID:f5306376-e7f2-44ad-8250-635b95428a7c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 866910

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Colesevelam Hydrochloride" or generic name "Colesevelam Hydrochloride"

    NDCBrand NameGeneric Name
    0115-1320Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDE
    0713-0935COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE
    0713-0936COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE
    27808-190Colesevelam hydrochlorideColesevelam hydrochloride
    42291-147Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDE
    43598-230Colesevelam HydrochlorideColesevelam Hydrochloride
    51407-159Colesevelam HydrochlorideColesevelam Hydrochloride
    51407-336Colesevelam hydrochlorideColesevelam hydrochloride
    51660-995Colesevelam hydrochloridecolesevelam hydrochloride
    51660-996Colesevelam hydrochloridecolesevelam hydrochloride
    60687-385Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDE
    68462-620Colesevelam HydrochlorideColesevelam Hydrochloride
    68462-433colesevelam hydrochloridecolesevelam hydrochloride
    67877-523Colesevelam hydrochlorideColesevelam hydrochloride
    69452-158COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE
    75834-152colesevelam hydrochloridecolesevelam hydrochloride
    0713-0879Welcholcolesevelam hydrochloride
    0713-0880Welcholcolesevelam hydrochloride
    21695-779Welcholcolesevelam hydrochloride
    21695-781Welcholcolesevelam hydrochloride
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