Prescription drug · ANDA
Fosphenytoin Sodium NDC 25021-798
Fosphenytoin sodium 50 mg/mL · Injection, Solution · Intramuscular, Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-798-02 | 25021079802 | 25 VIAL in 1 CARTON (25021-798-02) / 2 mL in 1 VIALMarketed from Jan 15, 2025 | |
| 25021-798-10 | 25021079810 | 10 VIAL in 1 CARTON (25021-798-10) / 10 mL in 1 VIALMarketed from Jan 15, 2025 |
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)
- Fosphenytoin Sodium
- Generic name (nonproprietary)
- fosphenytoin sodium
- Active ingredients
- Fosphenytoin sodium — 50 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214926
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 2D6 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 25021-798_20212ecb-248d-4fc6-b88d-c54a18076845SPL ID 20212ecb-248d-4fc6-b88d-c54a18076845SPL set ID e1dab8ad-cbf6-4273-92fa-02629de2abdeRxCUI 1670195, 1670200UNII 7VLR55452Z
- Pharmacologic class
- Anti-epileptic Agent
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N425021079802followed by a unit qualifier and the quantityPackage 25021-0798-02. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 214926
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 |
|---|---|---|---|---|
| Fosphenytoin sodium | Fosphenytoin sodium 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-621 |
| Fosphenytoin sodium | Fosphenytoin sodium 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-622 |
| Fosphenytoin sodium | Fosphenytoin sodium 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Gland Pharma Limited | 68083-460 |
| Fosphenytoin sodium | Fosphenytoin sodium 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Gland Pharma Limited | 68083-461 |
| Fosphenytoin sodium | Fosphenytoin sodium 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-945 |