NDC 67877-523

Colesevelam hydrochloride

Colesevelam Hydrochloride

Colesevelam hydrochloride is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Colesevelam Hydrochloride.

Product ID67877-523_55a80be9-ba23-4528-845d-5c01b16f80c3
NDC67877-523
Product TypeHuman Prescription Drug
Proprietary NameColesevelam hydrochloride
Generic NameColesevelam Hydrochloride
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date2019-05-09
Marketing CategoryANDA / ANDA
Application NumberANDA210316
Labeler NameAscend Laboratories, LLC
Substance NameCOLESEVELAM HYDROCHLORIDE
Active Ingredient Strength4 g/1
Pharm ClassesBile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 67877-523-30

30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30)
Marketing Start Date2019-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67877-523-30 [67877052330]

Colesevelam hydrochloride POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA210316
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-09

Drug Details

Active Ingredients

IngredientStrength
COLESEVELAM HYDROCHLORIDE3.75 g/1

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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