Prescription drug · ANDA
sevelamer hydrochloride NDC 68462-447
Sevelamer hydrochloride 800 mg/1 · Tablet, Film coated · Parenteral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-447-18 | 6846204471868462044718 | 180 TABLET, FILM COATED in 1 BOTTLE (68462-447-18)Marketed from Feb 8, 2019 | |
| 68462-447-30 | 6846204473068462044730 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-447-30)Marketed from Feb 8, 2019 |
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 hydrochloride
- Generic name (nonproprietary)
- sevelamer hydrochloride
- Active ingredients
- Sevelamer hydrochloride — 800 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Parenteral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204724
- Marketing start
- Listing expires
- Other FDA classes
- Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 68462-447_5b27539f-4664-4a6b-abe4-2abcc7ad2279SPL ID 5b27539f-4664-4a6b-abe4-2abcc7ad2279SPL set ID 2cd6512f-0edd-4a30-a4fa-aa996038633cRxCUI 857216, 857224UNII GLS2PGI8QGUPC 0368462447185, 0368462446263
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N468462044718followed by a unit qualifier and the quantityPackage 68462-0447-18. 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)
1. INDICATIONS AND USAGE Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. • Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68462-447
- What is NDC 68462-447?
- 68462-447 is the product NDC for sevelamer hydrochloride, Sevelamer hydrochloride 800 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- sevelamer hydrochloride.
- What is the active ingredient?
- Sevelamer hydrochloride.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 hydrochloride?
- 12 other product NDCs are listed under this name. See all sevelamer hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other sevelamer hydrochloride 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 Hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 70710-2058 | 70710-2058-08 |
| sevelamer hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedParenteral | Cardinal Health 107, LLC | 55154-2647 | 55154-2647-00 |
| sevelamer hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedParenteral | Major Pharmaceuticals | 0904-7209 | 00904-7209-06 |
| Sevelamer Hydrochloride | Sevelamer hydrochloride 400 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-087 | 59651-0087-36 |
| Sevelamer Hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-088 | 59651-0088-18 |
| Sevelamer Hydrochloride | Sevelamer hydrochloride 400 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-241 | 33342-0241-65 |
| Sevelamer Hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-242 | 33342-0242-0733342-0242-57 |
| Sevelamer Hydrochloride | Sevelamer hydrochloride 400 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2500 | 72162-2500-02 |
| Sevelamer Hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2501 | 72162-2501-02 |
| Sevelamer hydrochloride | Sevelamer hydrochloride 800 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 70748-173 | 70748-0173-26 |
Other NDCs under ANDA 204724
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 hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedParenteral | Major Pharmaceuticals | 0904-7209 |
| sevelamer hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedParenteral | Cardinal Health 107, LLC | 55154-2647 |
| Sevelamer Hydrochloride | Sevelamer hydrochloride 800 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-449 |
| sevelamer hydrochloride | Sevelamer hydrochloride 400 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-446 |