Prescription drug · ANDA
Choleystyramine Light NDC 67877-422
Cholestyramine 4 g/5.718g · Powder, For suspension · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-422-24 | 6787704222467877042224 | 240.156 g in 1 JAR (67877-422-24)Marketed from Oct 20, 2021 | |
| 67877-422-60 | 6787704226067877042260 | 60 POUCH in 1 CARTON (67877-422-60) / 5.718 g in 1 POUCH (67877-422-57)Marketed from Oct 20, 2021 |
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)
- Choleystyramine Light
- Generic name (nonproprietary)
- choleystyramine light
- Active ingredients
- Cholestyramine — 4 g/5.718g
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211799
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 67877-422_4880e0f1-3a01-431b-92ae-8cf788c73c41SPL ID 4880e0f1-3a01-431b-92ae-8cf788c73c41SPL set ID 4c9d4561-d5b5-463b-ac57-1bc4d84d135dRxCUI 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
N467877042224followed by a unit qualifier and the quantityPackage 67877-0422-24. 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 powder 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 powder 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 v…
Excerpt only. Read the full label for complete information.
About NDC 67877-422
- What is NDC 67877-422?
- 67877-422 is the product NDC for Choleystyramine Light, Cholestyramine 4 g/5.718g powder, for suspension, listed with the FDA by Ascend Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Choleystyramine Light.
- What is the active ingredient?
- Cholestyramine.
- Who is the labeler?
- Ascend Laboratories, LLC, NDC labeler code 67877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Choleystyramine Light?
- 1 other product NDC are listed under this name. See all Choleystyramine Light NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Choleystyramine Light products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Choleystyramine Light | Cholestyramine 4 g/5.718g | Powder, For suspensionOral | Bryant Ranch Prepack | 63629-9466 | 63629-9466-01 |
Other NDCs under ANDA 211799
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 |
|---|---|---|---|---|
| Choleystyramine Light | Cholestyramine 4 g/5.718g | Powder, For suspensionOral | Bryant Ranch Prepack | 63629-9466 |