Prescription drug · ANDA
Phenytoin Sodium NDC 42192-614
Phenytoin sodium 50 mg/mL · Injection · Intramuscular, Intravenous · Acella Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42192-614-10 | 42192061410 | 10 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIALMarketed from Dec 30, 2021 | |
| 42192-614-30 | 42192061430 | 10 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIALMarketed from Dec 30, 2021 |
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)
- Phenytoin Sodium
- Generic name (nonproprietary)
- phenytoin sodium
- Active ingredients
- Phenytoin sodium — 50 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Acella Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040573
- 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 42192-614_ae14cce7-f65a-45e0-8ff4-9388d0a806d2SPL ID ae14cce7-f65a-45e0-8ff4-9388d0a806d2SPL set ID 6922f32f-8bed-4c09-8103-27987bcbd104RxCUI 1670351, 1670353UNII 4182431BJH
- 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
N442192061410followed by a unit qualifier and the quantityPackage 42192-0614-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous Phenytoin Sodium Injection can also be substituted, as short-term use, for oral phenytoin. Parenteral Phenytoin should be used only when oral phenytoin administration is not possible [ see Dosage and Administration ( 2.1 , 2.3 ) and Warnings and Precautions (5.1) ]. Parenteral phenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Intravenous phenytoin can also be substitute…
Excerpt only. Read the full label for complete information.