What is NDC 0115-1864?

0115-1864 is the product NDC for Colesevelam hydrochloride, Colesevelam hydrochloride 3.75 g/1 for 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 Colesevelam hydrochloride?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Colesevelam hydrochloride NDC 0115-1864

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1864Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1864Add 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
0115-1864-18	0011518641800115186418	30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30)Marketed from Jan 20, 2023

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): Colesevelam hydrochloride
Generic name (nonproprietary): colesevelam hydrochloride
Active ingredients: Colesevelam hydrochloride — 3.75 g/1
Dosage form: For 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 212886
Marketing start: Jan 20, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 0115-1864_83f79a9e-7658-4d89-a3aa-8c5ee39ac846SPL ID 83f79a9e-7658-4d89-a3aa-8c5ee39ac846SPL set ID f33fbf30-2486-49a7-bbe8-0ddfb4b9b786RxCUI 866905UNII P4SG24WI5QUPC 0301151864306, 0301151864184
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

N400115186418 followed by a unit qualifier and the quantity

Package 00115-1864-18. 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 Oct 18, 2022.

Indications (excerpt from the label)

Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1.1 ). reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification ( 1.1 ). Limitations of Use ( 1.3 ): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias. improve glycemic control in adults with type 2 diabetes mellitus ( 1.2 ). 1.1 Primary …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-1864

What is NDC 0115-1864?: 0115-1864 is the product NDC for Colesevelam hydrochloride, Colesevelam hydrochloride 3.75 g/1 for 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?: Colesevelam hydrochloride.
What is the active ingredient?: Colesevelam 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 Colesevelam hydrochloride?: 20 other product NDCs are listed under this name. See all Colesevelam 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 Colesevelam hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-582	69452-0582-25
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	Bionpharma Inc.	69452-493	69452-0493-25
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-197	33342-0197-57
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6994	50090-6994-00
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6995	50090-6995-00
Colesevelam hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	Cranbury Pharmaceuticals, LLC	27808-190	27808-0190-01
Colesevelam hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	A-S Medication Solutions	50090-7604	50090-7604-00
Colesevelam hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	A-S Medication Solutions	50090-7605	50090-7605-00
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-336	51407-0336-18
Colesevelam Hydrochloride	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-158	69452-0158-25

All 21 Colesevelam hydrochloride NDCs