Prescription drug · ANDA
Sevelamer Carbonate NDC 65162-058
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-058-03 | 6516200580365162005803 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-058-03)Marketed from Jul 13, 2023 | |
| 65162-058-06 | 6516200580665162005806 | 60 TABLET, FILM COATED in 1 BOTTLE (65162-058-06)Marketed from Jul 13, 2023 | |
| 65162-058-09 | 6516200580965162005809 | 90 TABLET, FILM COATED in 1 BOTTLE (65162-058-09)Marketed from Nov 28, 2017 | |
| 65162-058-11 | 6516200581165162005811 | 1000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11)Marketed from Nov 28, 2017 | |
| 65162-058-27 | 6516200582765162005827 | 270 TABLET, FILM COATED in 1 BOTTLE (65162-058-27)Marketed from Nov 28, 2017 | |
| 65162-058-50 | 6516200585065162005850 | 500 TABLET, FILM COATED in 1 BOTTLE (65162-058-50)Marketed from Nov 28, 2017 |
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)
- Sevelamer Carbonate
- Generic name (nonproprietary)
- sevelamer carbonate
- Active ingredients
- Sevelamer carbonate — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207288
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 65162-058_53f81fb7-7bbc-430f-a2e4-841b58e2cb7cSPL ID 53f81fb7-7bbc-430f-a2e4-841b58e2cb7cSPL set ID 94d8cfb1-ff2a-4956-8954-17635ac505d9RxCUI 749206UNII 9YCX42I8IUUPC 0365162058277
- 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
N465162005803followed by a unit qualifier and the quantityPackage 65162-0058-03. 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)
Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate tablets are a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 65162-058
- What is NDC 65162-058?
- 65162-058 is the product NDC for Sevelamer Carbonate, Sevelamer carbonate 800 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sevelamer Carbonate.
- What is the active ingredient?
- Sevelamer carbonate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sevelamer Carbonate?
- 47 other product NDCs are listed under this name. See all Sevelamer Carbonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sevelamer Carbonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | INSIGNAMEDEX LLC | 87367-266 | 87367-0266-12 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Marp Pharma | 85898-101 | 85898-0101-27 |
| Sevelamer carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-2170 | 70710-2170-0370710-2170-0770710-2170-08 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | TabletOral | AiPing Pharmaceutical, Inc. | 11788-116 | 11788-0116-07 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-562 | 72789-0562-94 |
| Sevelamer carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Navinta LLC | 68475-010 | 68475-0010-0168475-0010-0268475-0010-03 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-014 | 73190-0014-27 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-423 | 69367-0423-27 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Shandong Xinhua Pharmaceutical Co., Ltd. | 58624-5001 | 58624-5001-0258624-5001-04 |
| Sevelamer Carbonate | Sevelamer carbonate .8 g/1 | Powder, For suspensionOral | NorthStar RxLLC | 72603-398 | 72603-0398-02 |
Other NDCs under ANDA 207288
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 |
|---|---|---|---|---|
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-720 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Precision Dose, Inc. | 68094-034 |