Prescription drug · ANDA
Colesevelam HCL NDC 71335-2905
Colesevelam hydrochloride 625 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2905-1 | 71335290501 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2905-1)Marketed from Nov 7, 2025 |
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
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 71335-2905_45993b3b-2611-4179-9a69-bec19879d7c2SPL ID 45993b3b-2611-4179-9a69-bec19879d7c2SPL set ID 22cf31e6-59fa-40db-a181-2a12afc3af43RxCUI 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
N471335290501followed by a unit qualifier and the quantityPackage 71335-2905-01. 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 .
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.
Other NDCs under ANDA 209038
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 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 | Bryant Ranch Prepack | 63629-8767 |
| 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 | 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 |