NDC codes

FDA NDC Directory
Product NDC (as listed)70518-0841Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-0841Add 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
70518-0841-0705180841007051808410030 TABLET, CHEWABLE in 1 BLISTER PACK (70518-0841-0)Marketed from Nov 10, 2017
70518-0841-3705180841037051808410350 POUCH in 1 BOX (70518-0841-3) / 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2)Marketed from Apr 25, 2026

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 — 50 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
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 70518-0841_522f9466-a36b-e74a-e063-6394a90af379SPL ID 522f9466-a36b-e74a-e063-6394a90af379SPL set ID 31e8a777-75b1-4f48-9682-0bcc3189ad26RxCUI 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

N470518084100 followed by a unit qualifier and the quantity

Package 70518-0841-00. 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)

About NDC 70518-0841

What is NDC 70518-0841?
70518-0841 is the product NDC for Phenytoin, Phenytoin 50 mg/1 tablet, chewable, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, 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?
REMEDYREPACK INC., NDC labeler code 70518. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Phenytoin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralRising Pharma Holdings, Inc.64980-57364980-0573-01
PhenytoinPhenytoin 125 mg/5mLSuspensionOralMylan Pharmaceuticals Inc.59762-053159762-0531-02
PhenytoinPhenytoin 125 mg/5mLSuspensionOralAmerican Health Packaging60687-27560687-0275-66
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralAmerican Health Packaging60687-15660687-0156-25
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralNCS HealthCare of KY, LLC dba Vangard Labs0615-862300615-8623-39
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralMajor Pharmaceuticals0904-719900904-7199-07
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralSun Pharmaceutical Industries, Inc.51672-414651672-4146-0151672-4146-0351672-4146-06
PhenytoinPhenytoin 125 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-089200121-0892-63
PhenytoinPhenytoin 125 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-407017856-4070-01
PhenytoinPhenytoin 125 mg/5mLSuspensionOralSun Pharmaceutical Industries, Inc.51672-406951672-4069-02

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, ChewableOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8623
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralMajor Pharmaceuticals0904-7199
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralSun Pharmaceutical Industries, Inc.51672-4146
PhenytoinPhenytoin 50 mg/1Tablet, ChewableOralAmerican Health Packaging60687-156

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