Colesevelam hydrochloride NDC 63629-8860

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8860Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8860Add 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
63629-8860-1	63629886001	30 PACKET in 1 CARTON (63629-8860-1) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Aug 19, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 3.75 g/1
Dosage form: Powder, For suspension
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210316
Marketing start: May 9, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 63629-8860_ea570adf-f7b9-4e17-a7db-92e9f70a1dbeSPL ID ea570adf-f7b9-4e17-a7db-92e9f70a1dbeSPL set ID 652fbd7b-2702-4db6-8691-be93c61bd9d6RxCUI 866905UNII 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

N463629886001 followed by a unit qualifier and the quantity

Package 63629-8860-01. 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 Jul 25, 2024.

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 postmenarchal girls, 10 to 17 years of age, with heteroz ygous familial hypercholesterolemia (HeFH) ( 1.1 ). Limitations of Use ( 1.3 ): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. The effect on cardiovascular morbidity and mortality has not been determined. Not studied in type 2 diabetes with a dipeptidyl peptidase 4 inhibitor. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias. Not studied in children less than…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210316

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

FDA NDC Directory listings under ANDA 210316
Product	Strength	Form · route	Labeler	Product NDC
Colesevelam hydrochloride	Colesevelam hydrochloride 3.75 g/1	Powder, For suspensionOral	Bryant Ranch Prepack	72162-1847
Colesevelam hydrochloride	Colesevelam hydrochloride 3.75 g/1	Powder, For suspensionOral	Ascend Laboratories, LLC	67877-523