NDC codes

FDA NDC Directory
Product NDC (as listed)0071-0007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00071-0007Add 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
0071-0007-240007100072400071000724100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24)Marketed from Feb 26, 1979

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)
Dilantin Infatabs
Generic name (nonproprietary)
phenytoin
Active ingredients
Phenytoin — 50 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Labeler
Parke-Davis Div of Pfizer IncNDC labeler code 0071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 084427
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 0071-0007_80f0cff3-357e-4328-860e-bbd525d80e6bSPL ID 80f0cff3-357e-4328-860e-bbd525d80e6bSPL set ID ca119a89-2394-4d34-8078-cd1fa4e8e2f1RxCUI 1313885, 1313887UNII 6158TKW0C5UPC 0300710007246
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

N400071000724 followed by a unit qualifier and the quantity

Package 00071-0007-24. 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)

DILANTIN 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. DILANTIN 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.

Full label on DailyMed (opens in a new tab)

About NDC 0071-0007

What is NDC 0071-0007?
0071-0007 is the product NDC for Dilantin Infatabs (phenytoin), Phenytoin 50 mg/1 tablet, chewable, listed with the FDA by Parke-Davis Div of Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dilantin Infatabs (Phenytoin).
What is the active ingredient?
Phenytoin.
Who is the labeler?
Parke-Davis Div of Pfizer Inc, NDC labeler code 0071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dilantin Infatabs?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 084427

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

FDA NDC Directory listings under ANDA 084427
ProductStrengthForm · routeLabelerProduct NDC
Phenytoin InfatabsphenytoinPhenytoin 50 mg/1Tablet, ChewableOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8424
Phenytoin InfatabsphenytoinPhenytoin 50 mg/1Tablet, ChewableOralPrasco Laboratories66993-372

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