Prescription drug · ANDA
Sevelamer Carbonate NDC 55111-789
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · DR. REDDY'S LABORATORIES LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-789-11 | 5511107891155111078911 | 25 BLISTER PACK in 1 CARTON (55111-789-11) / 4 TABLET, FILM COATED in 1 BLISTER PACK (55111-789-48)Marketed from Dec 12, 2018 | |
| 55111-789-27 | 5511107892755111078927 | 270 TABLET, FILM COATED in 1 BOTTLE (55111-789-27)Marketed from Sep 29, 2017 | |
| 55111-789-30 | 5511107893055111078930 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-789-30)Marketed from Sep 29, 2017 | |
| 55111-789-90 | 5511107899055111078990 | 90 TABLET, FILM COATED in 1 BOTTLE (55111-789-90)Marketed from Sep 29, 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
- DR. REDDY'S LABORATORIES LIMITEDNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206094
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 55111-789_f4b7a1eb-7592-27f3-1316-50b7d2538cd1SPL ID f4b7a1eb-7592-27f3-1316-50b7d2538cd1SPL set ID 0085356d-5fec-3cce-2bd3-108be70e515dRxCUI 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
N455111078911followed by a unit qualifier and the quantityPackage 55111-0789-11. 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 tablet is 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 55111-789
- What is NDC 55111-789?
- 55111-789 is the product NDC for Sevelamer Carbonate, Sevelamer carbonate 800 mg/1 tablet, film coated, listed with the FDA by DR. REDDY'S LABORATORIES LIMITED. It has 4 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?
- DR. REDDY'S LABORATORIES LIMITED, NDC labeler code 55111. 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 206094
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 | Major Pharmaceuticals | 0904-6707 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-706 |
| Sevelamer Carbonate | Sevelamer carbonate 800 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3358 |