Colesevelam Hydrochloride NDC 69452-158

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-158Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0158Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
69452-158-25	69452015825	180 TABLET, FILM COATED in 1 BOTTLE (69452-158-25)Marketed from Dec 2, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Colesevelam Hydrochloride
Generic name (nonproprietary): colesevelam hydrochloride
Active ingredients: Colesevelam hydrochloride — 625 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bionpharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208670
Marketing start: Dec 2, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 69452-158_30b35341-6379-12e6-e063-6394a90ad2c6SPL ID 30b35341-6379-12e6-e063-6394a90ad2c6SPL set ID a2c5e881-2901-4f90-95cc-74930569e51eRxCUI 866910UNII P4SG24WI5Q
Pharmacologic class: Bile Acid Sequestrant

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469452015825 followed by a unit qualifier and the quantity

Package 69452-0158-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 19, 2025.

Indications (excerpt from the label)

Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1.1 ). reduce LDL-C levels in boys and post-menarchal girls, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification ( 1.1 ). improve glycemic control in adults with type 2 diabetes mellitus ( 1.2 ). Limitations of Use ( 1.3 ): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias. 1.1 P…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208670

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208670
Product	Strength	Form · route	Labeler	Product NDC
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	Bionpharma Inc.	69452-493