Prescription drug · ANDA
Sevelamer Carbonate NDC 65862-921
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-921-18 | 6586209211865862092118 | 180 TABLET, FILM COATED in 1 BOTTLE (65862-921-18)Marketed from Jul 17, 2017 | |
| 65862-921-27 | 6586209212765862092127 | 270 TABLET, FILM COATED in 1 BOTTLE (65862-921-27)Marketed from Jul 17, 2017 | |
| 65862-921-30 | 6586209213065862092130 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-921-30)Marketed from Jul 17, 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
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207179
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 65862-921_761597e6-1a2e-48e7-b657-c3fa781b4f6bSPL ID 761597e6-1a2e-48e7-b657-c3fa781b4f6bSPL set ID ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaabRxCUI 749206UNII 9YCX42I8IU
- 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
N465862092118followed by a unit qualifier and the quantityPackage 65862-0921-18. 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 65862-921
- What is NDC 65862-921?
- 65862-921 is the product NDC for Sevelamer Carbonate, Sevelamer carbonate 800 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 3 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 207179
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8239 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-814 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | ATLANTIC BIOLOGICALS CORP. | 17856-0921 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8188 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-328 |