Prescription drug · ANDA
Colestipol Hydrochloride NDC 42799-115
Colestipol hydrochloride 1 g/1 · Tablet · Oral · Edenbridge Pharmaceuticals LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42799-115-01 | 42799011501 | 120 TABLET in 1 BOTTLE (42799-115-01)Marketed from Nov 26, 2024 |
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)
- Colestipol Hydrochloride
- Generic name (nonproprietary)
- colestipol hydrochloride
- Active ingredients
- Colestipol hydrochloride — 1 g/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217667
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 42799-115_440d1d49-3eb7-42db-8536-9f0a91c46532SPL ID 440d1d49-3eb7-42db-8536-9f0a91c46532SPL set ID 03ca5800-4211-4383-a332-be88bd9b5304RxCUI 1048445UNII X7D10K905GUPC 0342799115016
- 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
N442799011501followed by a unit qualifier and the quantityPackage 42799-0115-01. 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)
INDICATIONS & USAGE Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those indiv…
Excerpt only. Read the full label for complete information.