Prescription drug · NDA AUTHORIZED GENERIC
Colestipol Hydrochloride NDC 59762-0260
Colestipol hydrochloride 5 g/5g · Granule, For suspension · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0260-1 | 5976202600159762026001 | 30 PACKET in 1 CARTON (59762-0260-1) / 5 g in 1 PACKETMarketed from Apr 4, 1977 | |
| 59762-0260-2 | 5976202600259762026002 | 90 PACKET in 1 CARTON (59762-0260-2) / 5 g in 1 PACKETMarketed from Apr 4, 1977 | |
| 59762-0260-3 | 5976202600359762026003 | 500 g in 1 BOTTLE (59762-0260-3)Marketed from Apr 4, 1977 |
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 — 5 g/5g
- Dosage form
- Granule, For suspension
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 59762
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 017563
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 59762-0260_a0444824-730e-4e63-9ddf-54461b1c4900SPL ID a0444824-730e-4e63-9ddf-54461b1c4900SPL set ID 4e89bf6e-c78a-402e-9cb2-8d02f6047d68RxCUI 1048450UNII 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
N459762026001followed by a unit qualifier and the quantityPackage 59762-0260-01. 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 granules are indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. Generally, colestipol hydrochloride granules have no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients. Therapy with lipid-altering agents…
Excerpt only. Read the full label for complete information.
About NDC 59762-0260
- What is NDC 59762-0260?
- 59762-0260 is the product NDC for Colestipol Hydrochloride, Colestipol hydrochloride 5 g/5g granule, for suspension, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 package NDCs, 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 59762. 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 | NorthStar Rx LLC | 72603-817 | 72603-0817-01 |
| 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 |
Other NDCs under NDA 017563
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 5 g/5g | Granule, For suspensionOral | Pharmacia & Upjohn Company LLC | 0009-0260 |