Prescription drug · ANDA
Sevelamer carbonate NDC 70771-1520
Sevelamer carbonate 800 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1520-0 | 7077115200070771152000 | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1520-0)Marketed from Sep 17, 2020 | |
| 70771-1520-4 | 7077115200470771152004 | 10 BLISTER PACK in 1 CARTON (70771-1520-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1520-2)Marketed from Sep 17, 2020 | |
| 70771-1520-8 | 7077115200870771152008 | 270 TABLET, FILM COATED in 1 BOTTLE (70771-1520-8)Marketed from Sep 17, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207759
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 70771-1520_39b27e86-2261-45f0-bdbf-13edbc8d6310SPL ID 39b27e86-2261-45f0-bdbf-13edbc8d6310SPL set ID cbdee883-ccc7-4c55-965d-b608a214b375RxCUI 749206UNII 9YCX42I8IUUPC 0368382824271
- 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
N470771152000followed by a unit qualifier and the quantityPackage 70771-1520-00. 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 .
About NDC 70771-1520
- What is NDC 70771-1520?
- 70771-1520 is the product NDC for Sevelamer carbonate, Sevelamer carbonate 800 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 207759
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 | Zydus Pharmaceuticals USA Inc. | 68382-824 |