Prescription drug · ANDA
Phenytoin Infatabs (Phenytoin) NDC 0615-8424
Phenytoin 50 mg/1 · Tablet, Chewable · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8424-39 | 00615842439 | 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39)Marketed from Feb 1, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Infatabs
- Generic name (nonproprietary)
- phenytoin
- Active ingredients
- Phenytoin — 50 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084427
- Marketing start
- Marketing end
- 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 0615-8424_44fa2cc3-a26a-4e4d-9087-a196c69d9ca5SPL ID 44fa2cc3-a26a-4e4d-9087-a196c69d9ca5SPL set ID 0d240b2b-bc5c-4989-a20b-54ed37a09a4fRxCUI 1313885UNII 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
N400615842439followed by a unit qualifier and the quantityPackage 00615-8424-39. 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 Infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin Infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0615-8424
- What is NDC 0615-8424?
- 0615-8424 is the product NDC for Phenytoin Infatabs (phenytoin), Phenytoin 50 mg/1 tablet, chewable, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenytoin Infatabs (Phenytoin).
- What is the active ingredient?
- Phenytoin.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phenytoin Infatabs?
- 1 other product NDC are listed under this name. See all Phenytoin Infatabs NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenytoin Infatabs products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenytoin Infatabsphenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | Prasco Laboratories | 66993-372 | 66993-0372-02 |
Other NDCs under ANDA 084427
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 |
|---|---|---|---|---|
| Dilantin Infatabsphenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | Parke-Davis Div of Pfizer Inc | 0071-0007 |
| Phenytoin Infatabsphenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | Prasco Laboratories | 66993-372 |