Prescription drug · NDA
Colestid (Colestipol hydrochloride) NDC 0009-0450
Colestipol hydrochloride 1 g/1 · Tablet · Oral · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-0450-03 | 0000904500300009045003 | 120 TABLET in 1 BOTTLE (0009-0450-03)Marketed from Jul 19, 1994 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Colestid
- Generic name (nonproprietary)
- colestipol hydrochloride
- Active ingredients
- Colestipol hydrochloride — 1 g/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Pharmacia & Upjohn Company LLCNDC labeler code 0009
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020222
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 0009-0450_62a88ff5-632d-4fe7-a4e5-1170f1c70dd3SPL ID 62a88ff5-632d-4fe7-a4e5-1170f1c70dd3SPL set ID 3e270911-f27b-44d4-b0a2-33506418cc1dRxCUI 1048445, 1048447UNII X7D10K905GUPC 0300090450038
- 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
N400009045003followed by a unit qualifier and the quantityPackage 00009-0450-03. 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. COLESTID 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, COLESTID 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 individuals at significantly increa…
Excerpt only. Read the full label for complete information.
About NDC 0009-0450
- What is NDC 0009-0450?
- 0009-0450 is the product NDC for Colestid (colestipol hydrochloride), Colestipol hydrochloride 1 g/1 tablet, listed with the FDA by Pharmacia & Upjohn Company LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colestid (Colestipol Hydrochloride).
- What is the active ingredient?
- Colestipol hydrochloride.
- Who is the labeler?
- Pharmacia & Upjohn Company LLC, NDC labeler code 0009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Colestid?
- 1 other product NDC are listed under this name. See all Colestid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Colestid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Colestidcolestipol hydrochloride | Colestipol hydrochloride 5 g/5g | Granule, For suspensionOral | Pharmacia & Upjohn Company LLC | 0009-0260 | 00009-0260-0200009-0260-17 |
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 |
|---|---|---|---|---|
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0450 |