NDC 69452-158

COLESEVELAM HYDROCHLORIDE

Colesevelam Hydrochloride

COLESEVELAM HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bionpharma Inc.. The primary component is Colesevelam Hydrochloride.

Product ID69452-158_0f4f6090-60fa-46b3-9141-2bca3e6d47dc
NDC69452-158
Product TypeHuman Prescription Drug
Proprietary NameCOLESEVELAM HYDROCHLORIDE
Generic NameColesevelam Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-12-02
Marketing CategoryANDA / ANDA
Application NumberANDA208670
Labeler NameBionpharma Inc.
Substance NameCOLESEVELAM HYDROCHLORIDE
Active Ingredient Strength625 mg/1
Pharm ClassesBile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69452-158-25

180 TABLET, FILM COATED in 1 BOTTLE (69452-158-25)
Marketing Start Date2019-12-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69452-158-25 [69452015825]

COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208670
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-02

Drug Details

Active Ingredients

IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/1

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 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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