Prescription drug · ANDA
Cholestyramine Light (cholestyramine) NDC 51224-009
Cholestyramine 4 g/4.8g · Powder, For suspension · Oral · TAGI Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51224-009-10 | 51224000910 | 201.6 g in 1 CAN (51224-009-10)Marketed from Nov 12, 2020 |
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)
- Cholestyramine Light
- Generic name (nonproprietary)
- cholestyramine
- Active ingredients
- Cholestyramine — 4 g/4.8g
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- TAGI Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209599
- Marketing start
- Marketing end
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 51224-009_fb8b0e9c-1750-4016-95c7-d7a49e09d463SPL ID fb8b0e9c-1750-4016-95c7-d7a49e09d463SPL set ID eb85a2c8-cdc3-48bb-844d-e220ae3701a0RxCUI 1801279UNII 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
N451224000910followed by a unit qualifier and the quantityPackage 51224-0009-10. 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, light 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 for oral suspension USP, light 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 dise…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209599
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/4.8g | Powder, For suspensionOral | Precision Dose, Inc. | 68094-906 |