Prescription drug · ANDA
Cholestyramine NDC 42806-265
Cholestyramine 4 g/9g · Powder, For suspension · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-265-98 | 4280602659842806026598 | 9 g in 1 POUCH (42806-265-98)Marketed from Dec 15, 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)
- Cholestyramine
- Generic name (nonproprietary)
- cholestyramine
- Active ingredients
- Cholestyramine — 4 g/9g
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- EPIC PHARMA, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074557
- Marketing start
- Listing expires
- Other FDA classes
- Bile-acid Binding Activity (Mechanism)
- Identifiers
- Product ID 42806-265_721f5a44-a2ff-4f41-a297-217a128a5a66SPL ID 721f5a44-a2ff-4f41-a297-217a128a5a66SPL set ID d02eca8c-18d4-4b11-bb16-08748543b04dRxCUI 848943UNII 4B33BGI082UPC 0342806265987
- 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
N442806026598followed by a unit qualifier and the quantityPackage 42806-0265-98. 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 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 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 vascular di…
Excerpt only. Read the full label for complete information.
About NDC 42806-265
- What is NDC 42806-265?
- 42806-265 is the product NDC for Cholestyramine, Cholestyramine 4 g/9g powder, for suspension, listed with the FDA by EPIC PHARMA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cholestyramine.
- What is the active ingredient?
- Cholestyramine.
- Who is the labeler?
- EPIC PHARMA, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cholestyramine?
- 21 other product NDCs are listed under this name. See all Cholestyramine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cholestyramine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-150 | 11788-0150-1711788-0150-60 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | Micro Labs Limited | 42571-508 | 42571-0508-29 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | Macleods Pharmaceuticals Limited | 33342-293 | 33342-0293-7033342-0293-71 |
| Cholestyramine | Cholestyramine 4 g/5.7g | Powder, For suspensionOral | Macleods Pharmaceuticals Limited | 33342-319 | 33342-0319-7033342-0319-7233342-0319-83 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | Precision Dose, Inc. | 68094-806 | 68094-0806-1068094-0806-20 |
| Cholestyramine | Cholestyramine 4 g/4.8g | Powder, For suspensionOral | Precision Dose, Inc. | 68094-906 | 68094-0906-1068094-0906-20 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-266 | 24658-0266-9324658-0266-9524658-0266-97 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | EPIC PHARMA, LLC | 42806-266 | 42806-0266-95 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | EPIC PHARMA, LLC | 42806-267 | 42806-0267-9342806-0267-97 |
| Cholestyramine | Cholestyramine 4 g/8.3g | Powder, For suspensionOral | TAGI Pharma, Inc. | 51224-011 | 51224-0011-1051224-0011-20 |
Other NDCs under ANDA 074557
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 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-266 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | EPIC PHARMA, LLC | 42806-266 |
| Cholestyramine | Cholestyramine 4 g/9g | Powder, For suspensionOral | EPIC PHARMA, LLC | 42806-267 |