NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7199Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7199Add 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
0904-7199-070090471990730 BLISTER PACK in 1 CARTON (0904-7199-07) / 1 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Apr 17, 2014

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
Generic name (nonproprietary)
phenytoin
Active ingredients
Phenytoin — 50 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200565
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 0904-7199_066e29d5-dcad-4017-a345-085432105a41SPL ID 066e29d5-dcad-4017-a345-085432105a41SPL set ID 08a9d26b-4419-43ec-98f3-43d4534c2e76RxCUI 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

N400904719907 followed by a unit qualifier and the quantity

Package 00904-7199-07. 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 chewable tablets 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 chewable tablets 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200565

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

FDA NDC Directory listings under ANDA 200565
ProductStrengthForm · routeLabelerProduct NDC
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralREMEDYREPACK INC.70518-0841
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8623
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralAmerican Health Packaging60687-156
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralSun Pharmaceutical Industries, Inc.51672-4146

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