Colesevelam HCL NDC 63629-8767

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8767Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8767Add 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
63629-8767-1	63629876701	180 TABLET, FILM COATED in 1 BOTTLE (63629-8767-1)Marketed from Oct 6, 2018

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 HCL
Generic name (nonproprietary): colesevelam hcl
Active ingredients: Colesevelam hydrochloride — 625 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209038
Marketing start: Oct 6, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 63629-8767_bdc02ee5-8bb2-4257-a872-eca50fd37a27SPL ID bdc02ee5-8bb2-4257-a872-eca50fd37a27SPL set ID 5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7RxCUI 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

N463629876701 followed by a unit qualifier and the quantity

Package 63629-8767-01. 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 14, 2026.

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 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209038

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

FDA NDC Directory listings under ANDA 209038
Product	Strength	Form · route	Labeler	Product NDC
Colesevelam HCL	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-476
Colesevelam HCL	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4371
Colesevelam HCL	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2905
Colesevelam HCL	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1846
Colesevelam HCL	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-506
Colesevelam HCL	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7811