Colestipol Hydrochloride NDC 0115-5211

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-5211Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-5211Add 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
0115-5211-02	00115521102	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02)Marketed from Aug 17, 2021
0115-5211-16	00115521116	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16)Marketed from Aug 17, 2021

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 — 1 g/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077510
Marketing start: Aug 17, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 0115-5211_f5447b9f-74de-4073-9a0b-fd84edf3fe2dSPL ID f5447b9f-74de-4073-9a0b-fd84edf3fe2dSPL set ID fa6c3e11-84e9-433d-aa74-7cd34336bbedRxCUI 1048445UNII X7D10K905GUPC 0301155211168
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

N400115521102 followed by a unit qualifier and the quantity

Package 00115-5211-02. 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 May 21, 2026.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077510

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

FDA NDC Directory listings under ANDA 077510
Product	Strength	Form · route	Labeler	Product NDC
Colestipol Hydrochloride	Colestipol hydrochloride 1 g/1	Tablet, Film coatedOral	American Health Packaging	60687-715