Prescription drug · ANDA
Cholestyramine NDC 63629-2164
Cholestyramine 4 g/9g · Powder, For suspension · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2164-1 | 63629216401 | 378 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
- Labeler
- Bryant Ranch Prepack
- 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
N463629216401followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 077204
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | Par Health USA, LLC | 49884-465 |
| Questrancholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | Par Health USA, LLC | 49884-936 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | Bryant Ranch Prepack | 72162-1504 |