Prescription drug · ANDA
Cholestyramine NDC 68382-528
Cholestyramine 4 g/9g · Powder, For suspension · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-528-42 | 68382052842 | 378 g in 1 CAN (68382-528-42)Marketed from Aug 1, 2018 | |
| 68382-528-60 | 68382052860 | 60 POUCH in 1 CARTON (68382-528-60) / 9 g in 1 POUCHMarketed from Aug 1, 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)
- 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 202901
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 68382-528_05ac7932-41c3-4434-8655-d47bfa6db8b0SPL ID 05ac7932-41c3-4434-8655-d47bfa6db8b0SPL set ID acc48703-c15b-4275-aa75-749f1c07dcbbRxCUI 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
N468382052842followed by a unit qualifier and the quantityPackage 68382-0528-42. 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 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 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 hypercholes…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202901
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 | Zydus Lifesciences Limited | 70771-1105 |