Colesevelam HCL

Product NDC: 71335-2905
11-digit product format: 713352905
Labeler code: 71335
Product ID: 71335-2905_45993b3b-2611-4179-9a69-bec19879d7c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colesevelam HCL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209038
Marketing category: ANDA
Marketing start: 2018-10-06
Substance: COLESEVELAM HYDROCHLORIDE
Active strength: 625 mg/1
Pharmacologic classes: Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2905_45993b3b-2611-4179-9a69-bec19879d7c2
SPL ID: 45993b3b-2611-4179-9a69-bec19879d7c2
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Colesevelam HCL
Generic name: Colesevelam HCL
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2018-10-06
Marketing category: ANDA
Application number: ANDA209038
Pharmacologic classes: Bile Acid Sequestrant [EPC]; Bile-acid Binding Activity [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
COLESEVELAM HYDROCHLORIDE	625 mg/1

Package NDC	Description	Marketing start	Sample
71335-2905-1	180 TABLET, FILM COATED in 1 BOTTLE (71335-2905-1)	2025-11-07	No

UNII	Preferred term	Registry number	Matched term
P4SG24WI5Q	COLESEVELAM HYDROCHLORIDE	182815-44-7	COLESEVELAM HYDROCHLORIDE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2905-1	71335290501	180 TABLET, FILM COATED in 1 BOTTLE (71335-2905-1)	2025-11-07	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Colesevelam HCL	Bryant Ranch Prepack	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	100