Prescription drug · NDA AUTHORIZED GENERIC
Colestipol Hydrochloride NDC 59762-0450
Colestipol hydrochloride 1 g/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0450-1 | 59762045001 | 120 TABLET in 1 BOTTLE (59762-0450-1)Marketed from Jul 19, 1994 |
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)
- Colestipol Hydrochloride
- Generic name (nonproprietary)
- colestipol hydrochloride
- Active ingredients
- Colestipol hydrochloride — 1 g/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020222
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 59762-0450_1b610c4a-a8dc-4a10-bd7a-3e94ca49ee9cSPL ID 1b610c4a-a8dc-4a10-bd7a-3e94ca49ee9cSPL set ID dae7d51e-c117-4c8a-b018-45b01ae46100RxCUI 1048445UNII X7D10K905G
- 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
N459762045001followed by a unit qualifier and the quantityPackage 59762-0450-01. 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 AND 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 ind…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020222
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 |
|---|---|---|---|---|
| Colestidcolestipol hydrochloride | Colestipol hydrochloride 1 g/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0450 |