Prescription drug · NDA
Fosrenol (Lanthanum carbonate) NDC 54092-256
Lanthanum carbonate 750 mg/1 · Powder · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54092-256-02 | 54092025602 | 9 CARTON in 1 PACKAGE (54092-256-02) / 10 POWDER in 1 CARTON (54092-256-01)Marketed from Sep 24, 2014 |
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)
- Fosrenol
- Generic name (nonproprietary)
- lanthanum carbonate
- Active ingredients
- Lanthanum carbonate — 750 mg/1
- Dosage form
- Powder
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 54092
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204734
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 54092-256_b29f2b53-6f45-447d-afb3-297ccc4ef8dbSPL ID b29f2b53-6f45-447d-afb3-297ccc4ef8dbSPL set ID f10776b2-2c25-4343-aabe-68f302e5cb54RxCUI 477347, 542465, 602635, 603112, 603122, 642452, 1551881, 1551884, 1551885, 1551886UNII 490D9F069T
- Pharmacologic class
- Phosphate Binder
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
N454092025602followed by a unit qualifier and the quantityPackage 54092-0256-02. 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)
FOSRENOL ® is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. FOSRENOL is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 54092-256
- What is NDC 54092-256?
- 54092-256 is the product NDC for Fosrenol (lanthanum carbonate), Lanthanum carbonate 750 mg/1 powder, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fosrenol (Lanthanum carbonate).
- What is the active ingredient?
- Lanthanum carbonate.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 54092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fosrenol?
- 4 other product NDCs are listed under this name. See all Fosrenol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fosrenol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fosrenollanthanum carbonate | Lanthanum carbonate 1000 mg/1 | PowderOral | Takeda Pharmaceuticals America, Inc. | 54092-257 | 54092-0257-02 |
| Fosrenollanthanum carbonate | Lanthanum carbonate 1000 mg/1 | Tablet, ChewableOral | Takeda Pharmaceuticals America, Inc. | 54092-254 | 54092-0254-90 |
| Fosrenollanthanum carbonate | Lanthanum carbonate 750 mg/1 | Tablet, ChewableOral | Takeda Pharmaceuticals America, Inc. | 54092-253 | 54092-0253-90 |
| Fosrenollanthanum carbonate | Lanthanum carbonate 500 mg/1 | Tablet, ChewableOral | Takeda Pharmaceuticals America, Inc. | 54092-252 | 54092-0252-90 |
Other NDCs under NDA 204734
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 |
|---|---|---|---|---|
| Fosrenollanthanum carbonate | Lanthanum carbonate 1000 mg/1 | PowderOral | Takeda Pharmaceuticals America, Inc. | 54092-257 |