Prescription drug · ANDA
Colesevelam Hydrochloride NDC 69452-493
Colesevelam hydrochloride 625 mg/1 · Tablet · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-493-25 | 69452049325 | 180 TABLET in 1 BOTTLE (69452-493-25)Marketed from Feb 12, 2026 |
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
- Bionpharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208670
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 69452-493_4aa52a76-fe49-5557-e063-6294a90ace04SPL ID 4aa52a76-fe49-5557-e063-6294a90ace04SPL set ID 4aa52225-9214-59dc-e063-6294a90a5f75RxCUI 866910UNII P4SG24WI5QUPC 0369452493250
- 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
N469452049325followed by a unit qualifier and the quantityPackage 69452-0493-25. 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 .
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.
Other NDCs under ANDA 208670
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Colesevelam Hydrochloride | Colesevelam hydrochloride 625 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-158 |