NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2164Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2164Add 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
63629-2164-163629216401378 g in 1 CAN (63629-2164-1)Marketed from Sep 15, 2005

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)
Cholestyramine
Generic name (nonproprietary)
cholestyramine
Active ingredients
Cholestyramine — 4 g/9g
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077204
Marketing start
Listing expires
Other FDA classes
Bile-acid Binding Activity (Mechanism)
Identifiers
Product ID 63629-2164_d3c8b2d9-80f5-4ce6-a68b-f4bbf3aa9b1fSPL ID d3c8b2d9-80f5-4ce6-a68b-f4bbf3aa9b1fSPL set ID 2998a314-deb2-4a02-afab-7e8c868888e2RxCUI 848943UNII 4B33BGI082
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

N463629216401 followed by a unit qualifier and the quantity

Package 63629-2164-01. 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)

INDICATIONS AND USAGE 1) Cholestyramine for Oral Suspension USP is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077204

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

FDA NDC Directory listings under ANDA 077204
ProductStrengthForm · routeLabelerProduct NDC
CholestyramineCholestyramine 4 g/9gPowder, For suspensionOralPar Health USA, LLC49884-465
QuestrancholestyramineCholestyramine 4 g/9gPowder, For suspensionOralPar Health USA, LLC49884-936
CholestyramineCholestyramine 4 g/9gPowder, For suspensionOralBryant Ranch Prepack72162-1504

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