Prescription drug · ANDA
Colesevelam Hydrochloride NDC 33342-197
Colesevelam hydrochloride 625 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-197-57 | 33342019757 | 180 TABLET, FILM COATED in 1 BOTTLE (33342-197-57)Marketed from Apr 18, 2025 |
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, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204893
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 33342-197_c2075dd1-e33c-4438-95f8-1897f0e1f61aSPL ID c2075dd1-e33c-4438-95f8-1897f0e1f61aSPL set ID c2075dd1-e33c-4438-95f8-1897f0e1f61aRxCUI 866910UNII P4SG24WI5QUPC 0333342197573
- 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
N433342019757followed by a unit qualifier and the quantityPackage 33342-0197-57. 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 tablets are 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 dyslipi…
Excerpt only. Read the full label for complete information.