NDC codes

FDA NDC Directory
Product NDC (as listed)60687-275Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0275Add 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
60687-275-66606870275665 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
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

N460687027566 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-4070
PhenytoinPhenytoin 125 mg/5mLSuspensionOralSun Pharmaceutical Industries, Inc.51672-4069

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