Colestipol Hydrochloride NDC 0115-5212

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-5212Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-5212Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0115-5212-18	00115521218	30 SUSPENSION in 1 CARTON (0115-5212-18)Marketed from May 2, 2006
0115-5212-29	00115521229	90 SUSPENSION in 1 CARTON (0115-5212-29)Marketed from May 2, 2006

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): Colestipol Hydrochloride
Generic name (nonproprietary): colestipol hydrochloride
Active ingredients: Colestipol hydrochloride — 5 g/1
Dosage form: Suspension
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077277
Marketing start: May 2, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 0115-5212_78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06SPL ID 78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06SPL set ID 839354bd-cbac-4d18-8c02-b1b93766af38RxCUI 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

N400115521218 followed by a unit qualifier and the quantity

Package 00115-5212-18. 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 Dec 30, 2023.

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 for oral suspension is 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 for oral suspension has no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients. Therapy with l…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077277

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077277
Product	Strength	Form · route	Labeler	Product NDC
Colestipol Hydrochloride	Colestipol hydrochloride 5 g/1	SuspensionOral	Amneal Pharmaceuticals of New York LLC	0115-5213