NDC codes

FDA NDC Directory
Product NDC (as listed)69452-582Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0582Add 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
69452-582-2569452058225180 TABLET, FILM COATED in 1 BOTTLE (69452-582-25)Marketed from Sep 30, 2026

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
Bionpharma Inc.NDC labeler code 69452
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208670
Marketing start
Listing expires
Other FDA classes
Bile-acid Binding Activity (Mechanism)
Identifiers
Product ID 69452-582_5ca9a9b7-5efc-09bf-e063-6294a90a681dSPL ID 5ca9a9b7-5efc-09bf-e063-6294a90a681d
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

N469452058225 followed by a unit qualifier and the quantity

Package 69452-0582-25. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 69452-582

What is NDC 69452-582?
69452-582 is the product NDC for Colesevelam Hydrochloride, Colesevelam hydrochloride 625 mg/1 tablet, film coated, listed with the FDA by Bionpharma Inc.. 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?
Bionpharma Inc., NDC labeler code 69452. 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/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
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralBionpharma Inc.69452-15869452-0158-25

All 21 Colesevelam Hydrochloride NDCs

Other NDCs under ANDA 208670

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

FDA NDC Directory listings under ANDA 208670
ProductStrengthForm · routeLabelerProduct NDC
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1Tablet, Film coatedOralBionpharma Inc.69452-158
Colesevelam HydrochlorideColesevelam hydrochloride 625 mg/1TabletOralBionpharma Inc.69452-493

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