Prescription drug · ANDA
Sodium Polystyrene Sulfonate NDC 35573-108
Sodium polystyrene sulfonate 15 g/60mL · Suspension · Oral, Rectal · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-108-14 | 3557301081435573010814 | 10 BOTTLE, UNIT-DOSE in 1 CARTON (35573-108-14) / 60 mL in 1 BOTTLE, UNIT-DOSE (35573-108-13)Marketed from Dec 18, 2025 | |
| 35573-108-57 | 3557301085735573010857 | 473 mL in 1 BOTTLE (35573-108-57)Marketed from Jun 19, 2026 |
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 — 15 g/60mL
- Dosage form
- Suspension
- Route
- Oral, Rectal
- Labeler
- Burel Pharmaceuticals, LLCNDC labeler code 35573
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214912
- Marketing start
- Listing expires
- Identifiers
- Product ID 35573-108_609a9733-cc0e-48ed-b2e1-8d765a4650d7SPL ID 609a9733-cc0e-48ed-b2e1-8d765a4650d7SPL set ID 8bbeae67-a7ff-4fa6-b21e-fb8617cd9197RxCUI 313072UNII 1699G8679Z
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
N435573010814followed by a unit qualifier and the quantityPackage 35573-0108-14. 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)
INDICATION AND USAGE Sodium Polystyrene Sulfonate Suspension, USP is indicated for the treatment of hyperkalemia.
Excerpt only. Read the full label for complete information.
About NDC 35573-108
- What is NDC 35573-108?
- 35573-108 is the product NDC for Sodium Polystyrene Sulfonate, Sodium polystyrene sulfonate 15 g/60mL suspension, listed with the FDA by Burel Pharmaceuticals, 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?
- Burel Pharmaceuticals, LLC, NDC labeler code 35573. 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 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 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral | Epic Pharma, LLC | 42806-013 | 42806-0013-9442806-0013-96 |