Prescription drug · ANDA
Colestipol Hydrochloride NDC 72603-817
Colestipol hydrochloride 1 g/1 · Tablet, Film coated · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-817-01 | 7260308170172603081701 | 120 TABLET, FILM COATED in 1 BOTTLE (72603-817-01)Marketed from Sep 1, 2026 |
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, Film coated
- Route
- Oral
- Labeler
- NorthStar Rx LLCNDC labeler code 72603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216517
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 72603-817_515f9c9d-c91c-f5ac-e063-6294a90a2f3dSPL ID 515f9c9d-c91c-f5ac-e063-6294a90a2f3dSPL set ID 515f9b07-7c03-0a2b-e063-6394a90a617dRxCUI 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
N472603081701followed by a unit qualifier and the quantityPackage 72603-0817-01. 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.
About NDC 72603-817
- What is NDC 72603-817?
- 72603-817 is the product NDC for Colestipol Hydrochloride, Colestipol hydrochloride 1 g/1 tablet, film coated, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Colestipol Hydrochloride.
- What is the active ingredient?
- Colestipol hydrochloride.
- Who is the labeler?
- NorthStar Rx LLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Colestipol Hydrochloride?
- 11 other product NDCs are listed under this name. See all Colestipol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Colestipol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-284 | 50742-0284-12 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-115 | 42799-0115-01 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 62559-395 | 62559-0395-12 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | American Health Packaging | 60687-715 | 60687-0715-21 |
| Colestipol hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-1467 | 70710-1467-0570710-1467-07 |
| Colestipol hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1653 | 70771-1653-0570771-1653-07 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 0115-5211 | 00115-5211-0200115-5211-16 |
| Colestipol Hydrochloride | Colestipol hydrochloride 5 g/1 | SuspensionOral | Amneal Pharmaceuticals of New York LLC | 0115-5212 | 00115-5212-1800115-5212-29 |
| Colestipol Hydrochloride | Colestipol hydrochloride 5 g/1 | SuspensionOral | Amneal Pharmaceuticals of New York LLC | 0115-5213 | 00115-5213-02 |
| Colestipol Hydrochloride | Colestipol hydrochloride 1 g/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0450 | 59762-0450-01 |
Other NDCs under ANDA 216517
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 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 62559-395 |