What is NDC 0115-5213?

0115-5213 is the product NDC for Colestipol Hydrochloride, Colestipol hydrochloride 5 g/1 suspension, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Colestipol Hydrochloride NDC 0115-5213

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-5213Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-5213Add 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
0115-5213-02	0011552130200115521302	100 SUSPENSION in 1 BOTTLE (0115-5213-02)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 LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077277
Marketing start: May 2, 2006
Listing expires: Dec 31, 2027
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 0115-5213_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

N400115521302 followed by a unit qualifier and the quantity

Package 00115-5213-02. 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 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)

About NDC 0115-5213

What is NDC 0115-5213?: 0115-5213 is the product NDC for Colestipol Hydrochloride, Colestipol hydrochloride 5 g/1 suspension, listed with the FDA by Amneal Pharmaceuticals of New York 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Colestipol Hydrochloride NDCs
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 1 g/1	TabletOral	Mylan Pharmaceuticals Inc.	59762-0450	59762-0450-01

All 12 Colestipol Hydrochloride NDCs

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	0115-5212