NDC codes

FDA NDC Directory
Product NDC (as listed)72162-1846Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-1846Add 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 NDC11-digit (billing)PackageCopy
72162-1846-27216218460272162184602180 TABLET, FILM COATED in 1 BOTTLE (72162-1846-2)Marketed from Apr 20, 2023

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)
Colesevelam HCL
Generic name (nonproprietary)
colesevelam hcl
Active ingredients
Colesevelam hydrochloride — 625 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 72162
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209038
Marketing start
Listing expires
Other FDA classes
Bile-acid Binding Activity (Mechanism)
Identifiers
Product ID 72162-1846_20fff2f0-3ece-4464-977c-c897847df88eSPL ID 20fff2f0-3ece-4464-977c-c897847df88eSPL set ID ffac398c-3eb7-482a-80ce-0ad2cbd2bdcaRxCUI 866910UNII P4SG24WI5Q
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

N472162184602 followed by a unit qualifier and the quantity

Package 72162-1846-02. 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 .

Indications (excerpt from the label)

Colesevelam hydrochloride tablets 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) ( 1.1 ) Limitations of Use ( 1.3 ): •Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. •The effect on cardiovascular morbidity and mortality has not been determined. •Not studied in type 2 diabetes with a dipeptidyl peptidase 4 inhibitor. •Not studied in Fredrickson Type I, III, IV, and V dyslipidemias. •Not studied in chil…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72162-1846

What is NDC 72162-1846?
72162-1846 is the product NDC for Colesevelam HCL, Colesevelam hydrochloride 625 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Colesevelam HCL.
What is the active ingredient?
Colesevelam hydrochloride.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 72162. 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 HCL?
6 other product NDCs are listed under this name. See all Colesevelam HCL 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 HCL NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-437150090-4371-00
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-781150090-7811-00
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-876763629-8767-01
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-50667877-0506-0567877-0506-3067877-0506-51+1 more
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-290571335-2905-01
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-47672789-0476-93

Other NDCs under ANDA 209038

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

FDA NDC Directory listings under ANDA 209038
ProductStrengthForm · routeLabelerProduct NDC
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4371
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7811
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8767
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-506
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2905
Colesevelam HCLColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-476

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