Colesevelam hydrochloride NDC 27808-190

NDC codes

FDA NDC Directory

Product NDC (as listed)27808-190Labeler and product segments. Claims need a package NDC.

Product NDC at billing width27808-0190Add 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
27808-190-01	27808019001	180 TABLET in 1 BOTTLE (27808-190-01)Marketed from Oct 19, 2020

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
Route: Oral
Labeler: Cranbury Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209946
Marketing start: Oct 19, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 27808-190_47df1b20-2cfd-483e-94cc-232339869d17SPL ID 47df1b20-2cfd-483e-94cc-232339869d17SPL set ID 5e50cc0c-03bc-444b-9d15-ea112bc0f91cRxCUI 866910UNII P4SG24WI5QUPC 0327808190017
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

N427808019001 followed by a unit qualifier and the quantity

Package 27808-0190-01. 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 31, 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 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 Primary H…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209946

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

FDA NDC Directory listings under ANDA 209946
Product	Strength	Form · route	Labeler	Product NDC
Colesevelam hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	A-S Medication Solutions	50090-7604
Colesevelam hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	A-S Medication Solutions	50090-7605
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-336