colesevelam hydrochloride NDC 68462-433

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-433Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0433Add 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
68462-433-18	68462043318	180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18)Marketed from May 18, 2018
68462-433-90	68462043390	90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90)Marketed from May 18, 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 — 625 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203480
Marketing start: May 18, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Bile-acid Binding Activity (Mechanism)
Identifiers: Product ID 68462-433_169fb7d2-7872-46a4-99ab-94f46781348fSPL ID 169fb7d2-7872-46a4-99ab-94f46781348fSPL set ID 845b8661-0aa9-418f-a496-df3d7a3130ffRxCUI 866910UNII P4SG24WI5QUPC 0368462433188
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

N468462043318 followed by a unit qualifier and the quantity

Package 68462-0433-18. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 203480

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

FDA NDC Directory listings under ANDA 203480
Product	Strength	Form · route	Labeler	Product NDC
colesevelam hydrochloride	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7459
colesevelam hydrochloride	Colesevelam hydrochloride 625 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7460