Prescription drug · ANDA
Cholestyramine NDC 68094-806
Cholestyramine 4 g/9g · Powder, For suspension · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-806-10 | 68094080610 | 348.6 g in 1 CAN (68094-806-10)Marketed from Apr 25, 2024 | |
| 68094-806-20 | 68094080620 | 60 POUCH in 1 CARTON (68094-806-20) / 9 g in 1 POUCHMarketed from Apr 25, 2024 |
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
- Labeler
- Precision Dose, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209597
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 68094-806_7c0786fa-dc69-4bc6-aa53-664938642855SPL ID 7c0786fa-dc69-4bc6-aa53-664938642855SPL set ID 8c7fc9c8-318c-42de-a736-c439047d8af8RxCUI 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
N468094080610followed by a unit qualifier and the quantityPackage 68094-0806-10. 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 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 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 h…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209597
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/8.3g | Powder, For suspensionOral | TAGI Pharma, Inc. | 51224-011 |