Colesevelam hydrochloride NDC 67877-523

NDC codes

FDA NDC Directory

Product NDC (as listed)67877-523Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67877-0523Add 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
67877-523-30	67877052330	30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30)Marketed from May 9, 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 — 3.75 g/1
Dosage form: Powder, For suspension
Route: Oral
Labeler: Ascend Laboratories, LLC
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 67877-523_28be90eb-5090-4aba-ae6e-8a4332ccfbe2SPL ID 28be90eb-5090-4aba-ae6e-8a4332ccfbe2SPL set ID dfce5bc5-58fc-4fe5-b5c0-7a8026ee2b96RxCUI 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

N467877052330 followed by a unit qualifier and the quantity

Package 67877-0523-30. 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 Feb 16, 2023.

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 ). 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 Primary Hyperlipidemia Colesevelam hydrochloride for oral suspension is indicated a…

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	63629-8860
Colesevelam hydrochloride	Colesevelam hydrochloride 3.75 g/1	Powder, For suspensionOral	Bryant Ranch Prepack	72162-1847