Prescription drug · ANDA
Phenytoin NDC 60687-275
Phenytoin 125 mg/5mL · Suspension · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-275-66 | 60687027566 | 5 TRAY in 1 CASE (60687-275-66) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-275-63) / 4 mL in 1 CUP, UNIT-DOSE (60687-275-62)Marketed from Jan 10, 2019 |
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
- Generic name (nonproprietary)
- phenytoin
- Active ingredients
- Phenytoin — 125 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040521
- 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 60687-275_3f00559d-7f12-eadc-e063-6294a90a7962SPL ID 3f00559d-7f12-eadc-e063-6294a90a7962SPL set ID f9fe4c92-2761-4cb4-9cf3-7066e240e014RxCUI 1313112UNII 6158TKW0C5
- 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 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
N460687027566followed by a unit qualifier and the quantityPackage 60687-0275-66. 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)
Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040521
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 |
|---|---|---|---|---|
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0892 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-4070 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | Sun Pharmaceutical Industries, Inc. | 51672-4069 |