NDC codes

FDA NDC Directory
Product NDC (as listed)68462-620Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0620Add 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
68462-620-30684620620306846206203030 PACKET in 1 BOX (68462-620-30) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Jul 16, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Powder, For suspension
Route
Oral
Labeler
Glenmark Pharmaceuticals Inc.,USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202190
Marketing start
Listing expires
Other FDA classes
Bile-acid Binding Activity (Mechanism)
Identifiers
Product ID 68462-620_82044bf3-865e-4816-a6a2-f648d980fff2SPL ID 82044bf3-865e-4816-a6a2-f648d980fff2SPL set ID 2e736dd4-bb64-4f93-9821-7c24ea7d38ecRxCUI 866905UNII P4SG24WI5QUPC 0368462620304
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

N468462062030 followed by a unit qualifier and the quantity

Package 68462-0620-30. 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 for oral suspension 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 ). • improve glycemic control in adults with type 2 diabetes mellitus ( 1.2 ). 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-620

What is NDC 68462-620?
68462-620 is the product NDC for Colesevelam Hydrochloride, Colesevelam hydrochloride 3.75 g/1 powder, for suspension, listed with the FDA by Glenmark Pharmaceuticals Inc.,USA. 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?
Glenmark Pharmaceuticals Inc.,USA, NDC labeler code 68462. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralBionpharma Inc.69452-58269452-0582-25
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1TabletOralBionpharma Inc.69452-49369452-0493-25
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-19733342-0197-57
Colesevelam hydrochlorideColesevelam hydrochloride 3.75 g/1For suspensionOralAmneal Pharmaceuticals of New York LLC0115-186400115-1864-18
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-699450090-6994-00
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-699550090-6995-00
Colesevelam hydrochlorideColesevelam hydrochloride 625 mg/1TabletOralCranbury Pharmaceuticals, LLC27808-19027808-0190-01
Colesevelam hydrochlorideColesevelam hydrochloride 625 mg/1TabletOralA-S Medication Solutions50090-760450090-7604-00
Colesevelam hydrochlorideColesevelam hydrochloride 625 mg/1TabletOralA-S Medication Solutions50090-760550090-7605-00
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1TabletOralGolden State Medical Supply, Inc.51407-33651407-0336-18

All 21 Colesevelam Hydrochloride NDCs

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