NDC codes

FDA NDC Directory
Product NDC (as listed)17856-4070Labeler and product segments. Claims need a package NDC.
Product NDC at billing width17856-4070Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
17856-4070-11785640700172 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
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

N417856407001 followed by a unit qualifier and the quantity

Package 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 040521

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040521
ProductStrengthForm · routeLabelerProduct NDC
PhenytoinPhenytoin 125 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-0892
PhenytoinPhenytoin 125 mg/5mLSuspensionOralAmerican Health Packaging60687-275
PhenytoinPhenytoin 125 mg/5mLSuspensionOralSun Pharmaceutical Industries, Inc.51672-4069

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