Prescription drug · ANDA
Phenytoin NDC 17856-4070
Phenytoin 125 mg/5mL · Suspension · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-4070-1 | 1785640700117856407001 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-4070-1) / 4 mL in 1 CUP, UNIT-DOSE (17856-4070-2)Marketed from May 9, 2024 |
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)
- Phenytoin
- Generic name (nonproprietary)
- phenytoin
- Active ingredients
- Phenytoin — 125 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- ATLANTIC BIOLOGICALS CORP.NDC labeler code 17856
- 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 17856-4070_36335944-2d3c-b82e-e063-6294a90a705cSPL ID 36335944-2d3c-b82e-e063-6294a90a705cSPL set ID 09daf485-3355-44cb-92af-072dd281e129RxCUI 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
N417856407001followed by a unit qualifier and the quantityPackage 17856-4070-01. 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)
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.
About NDC 17856-4070
- What is NDC 17856-4070?
- 17856-4070 is the product NDC for Phenytoin, Phenytoin 125 mg/5mL suspension, listed with the FDA by ATLANTIC BIOLOGICALS CORP.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenytoin.
- What is the active ingredient?
- Phenytoin.
- Who is the labeler?
- ATLANTIC BIOLOGICALS CORP., NDC labeler code 17856. 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?
- 10 other product NDCs are listed under this name. See all Phenytoin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenytoin 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 | Phenytoin 50 mg/1 | Tablet, ChewableOral | Rising Pharma Holdings, Inc. | 64980-573 | 64980-0573-01 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | Mylan Pharmaceuticals Inc. | 59762-0531 | 59762-0531-02 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | American Health Packaging | 60687-275 | 60687-0275-66 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | REMEDYREPACK INC. | 70518-0841 | 70518-0841-0070518-0841-03 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | American Health Packaging | 60687-156 | 60687-0156-25 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8623 | 00615-8623-39 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | Major Pharmaceuticals | 0904-7199 | 00904-7199-07 |
| Phenytoin | Phenytoin 50 mg/1 | Tablet, ChewableOral | Sun Pharmaceutical Industries, Inc. | 51672-4146 | 51672-4146-0151672-4146-0351672-4146-06 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0892 | 00121-0892-63 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | Sun Pharmaceutical Industries, Inc. | 51672-4069 | 51672-4069-02 |
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 | Sun Pharmaceutical Industries, Inc. | 51672-4069 |
| Phenytoin | Phenytoin 125 mg/5mL | SuspensionOral | American Health Packaging | 60687-275 |