Prescription drug · ANDA
Colesevelam HCL NDC 72789-476
Colesevelam hydrochloride 625 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-476-93 | 72789047693 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-476-93)Marketed from Jan 23, 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 HCL
- Generic name (nonproprietary)
- colesevelam hcl
- Active ingredients
- Colesevelam hydrochloride — 625 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 72789-476_5b8a3d88-1421-c3b6-e063-6394a90a429cSPL ID 5b8a3d88-1421-c3b6-e063-6394a90a429c
- 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
N472789047693followed by a unit qualifier and the quantityPackage 72789-0476-93. 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
The FDA listing for this product does not reference a label (SPL) set.
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 | 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 | 71335-2905 |
| 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 |