Prescription drug · ANDA
Sodium Polystyrene Sulfonate NDC 63629-8849
Sodium polystyrene sulfonate 4.1 meq/g · Powder, For suspension · Oral, Rectal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8849-1 | 63629884901 | 15 g in 1 BOTTLE (63629-8849-1)Marketed from Sep 20, 2021 |
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)
- 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, Rectal
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204071
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-8849_beecdb86-1fa6-4739-b976-b4227eb671daSPL ID beecdb86-1fa6-4739-b976-b4227eb671daSPL set ID cae5e7d2-c6ca-485e-963e-1a147e5b11c3RxCUI 2101899UNII 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
N463629884901followed by a unit qualifier and the quantityPackage 63629-8849-01. 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 for suspension is indicated for the treatment of hyperkalemia. Limitation of Use : Sodium polystyrene sulfonate 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 for suspension is a potassium binder indicated for the treatment of hyperkalemia ( 1 ). Limitation of Use : Sodium polystyrene sulfonate for suspension should not be used an emergency treatment for life threatening hyperkalemia because of its delayed onset of action ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204071
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, Rectal | Bryant Ranch Prepack | 71335-2855 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Bryant Ranch Prepack | 63629-8850 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | SUNRISE PHARMACEUTICAL, INC. | 11534-166 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Bryant Ranch Prepack | 63629-2390 |
| Sodium Polystyrene Sulfonate | Sodium polystyrene sulfonate 4.1 meq/g | Powder, For suspensionOral, Rectal | Bryant Ranch Prepack | 72162-1230 |