Prescription drug · ANDA
Sodium Polystyrene Sulfonate NDC 42806-013
Sodium polystyrene sulfonate 4.1 meq/g · Powder, For suspension · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-013-94 | 4280600139442806001394 | 15 g in 1 BOTTLE (42806-013-94)Marketed from Sep 15, 2022 | |
| 42806-013-96 | 4280600139642806001396 | 453.6 g in 1 JAR (42806-013-96)Marketed from Apr 14, 2014 |
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)
- Sodium Polystyrene Sulfonate
- Generic name (nonproprietary)
- sodium polystyrene sulfonate
- Active ingredients
- Sodium polystyrene sulfonate — 4.1 meq/g
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Epic Pharma, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202333
- Marketing start
- Listing expires
- Identifiers
- Product ID 42806-013_b177069d-1a6b-490c-b17a-a2399d99685fSPL ID b177069d-1a6b-490c-b17a-a2399d99685fSPL set ID 61cc890b-eb3d-494c-ae45-629a27e721ceRxCUI 2101899UNII 1699G8679ZUPC 0342806013946
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
N442806001394followed by a unit qualifier and the quantityPackage 42806-0013-94. 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)
Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for the treatment of hyperkalemia. Limitation of Use: Sodium Polystyrene Sulfonate Powder, for Suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)] . Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for the treatment of hyperkalemia (1) . Limitation of Use: Sodium Polystyrene Sulfonate Powder, for Suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action (1) .
Excerpt only. Read the full label for complete information.
About NDC 42806-013
- What is NDC 42806-013?
- 42806-013 is the product NDC for Sodium Polystyrene Sulfonate, Sodium polystyrene sulfonate 4.1 meq/g powder, for suspension, listed with the FDA by Epic Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Polystyrene Sulfonate.
- What is the active ingredient?
- Sodium polystyrene sulfonate.
- Who is the labeler?
- Epic Pharma, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Polystyrene Sulfonate?
- 14 other product NDCs are listed under this name. See all Sodium Polystyrene Sulfonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Polystyrene Sulfonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 15 g/60mL | SuspensionOral, Rectal | Burel Pharmaceuticals, LLC | 35573-108 | 35573-0108-1435573-0108-57 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | SUNRISE PHARMACEUTICAL, INC. | 11534-166 | 11534-0166-1511534-0166-1611534-0166-44 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Bryant Ranch Prepack | 63629-2390 | 63629-2390-01 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Bryant Ranch Prepack | 63629-8849 | 63629-8849-01 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Bryant Ranch Prepack | 63629-8850 | 63629-8850-01 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Bryant Ranch Prepack | 71335-2855 | 71335-2855-01 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Bryant Ranch Prepack | 72162-1230 | 72162-1230-0272162-1230-07 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral | PuraCap Laboratories, LLC | 24658-760 | 24658-0760-16 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Chartwell RX, LLC | 62135-340 | 62135-0340-1162135-0340-5362135-0340-62 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0024 | 17856-0024-0117856-0024-02 |
Other NDCs under ANDA 202333
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 |
|---|---|---|---|---|
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0024 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral | PuraCap Laboratories, LLC | 24658-760 |