NDC 70771-1368

COLESEVELAM

Colesevelam

COLESEVELAM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Colesevelam Hydrochloride.

Product ID70771-1368_47ee247c-041c-4eaa-bc2e-831064e6d4db
NDC70771-1368
Product TypeHuman Prescription Drug
Proprietary NameCOLESEVELAM
Generic NameColesevelam
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-10-11
Marketing CategoryANDA / ANDA
Application NumberANDA207765
Labeler NameZydus Lifesciences Limited
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 70771-1368-0

1000 TABLET in 1 BOTTLE (70771-1368-0)
Marketing Start Date2019-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1368-2 [70771136802]

COLESEVELAM TABLET
Marketing CategoryANDA
Application NumberANDA207765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-11

NDC 70771-1368-0 [70771136800]

COLESEVELAM TABLET
Marketing CategoryANDA
Application NumberANDA207765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-11

NDC 70771-1368-8 [70771136808]

COLESEVELAM TABLET
Marketing CategoryANDA
Application NumberANDA207765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-11

NDC 70771-1368-4 [70771136804]

COLESEVELAM TABLET
Marketing CategoryANDA
Application NumberANDA207765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/1

OpenFDA Data

SPL SET ID:090eabd5-acd3-43ed-a05b-52f1f3773a93
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 866910
  • UPC Code
  • 0370771136889
  • 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" or generic name "Colesevelam"

    NDCBrand NameGeneric Name
    27808-190ColesevelamColesevelam
    68382-619ColesevelamColesevelam
    70771-1368COLESEVELAMCOLESEVELAM

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