Prescription drug · ANDA

Phenytoin Sodium NDC 50090-5700

Phenytoin sodium 100 mg/1 · Capsule, Extended release · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-5700Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5700Add 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
50090-5700-050090570000100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5700-0)Marketed from Sep 23, 2021
50090-5700-15009057000190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5700-1)Marketed from Sep 24, 2021

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 Sodium
Generic name (nonproprietary)
phenytoin sodium
Active ingredients
Phenytoin sodium — 100 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040684
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 50090-5700_452ba779-0f51-4e9d-a661-e3db5078e950SPL ID 452ba779-0f51-4e9d-a661-e3db5078e950SPL set ID d4459837-da26-4c97-8587-32eb1f682d58RxCUI 855671UNII 4182431BJH
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

N450090570000 followed by a unit qualifier and the quantity

Package 50090-5700-00. 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)

Extended phenytoin sodium capsules, USP are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and 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 50090-5700

What is NDC 50090-5700?
50090-5700 is the product NDC for Phenytoin Sodium, Phenytoin sodium 100 mg/1 capsule, extended release, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Phenytoin Sodium.
What is the active ingredient?
Phenytoin sodium.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. 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 Sodium?
26 other product NDCs are listed under this name. See all Phenytoin Sodium 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 Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralCoupler LLC67046-058567046-0585-03
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralAvPAK50268-71950268-0719-13
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-741600904-7416-61
Phenytoin SodiumPhenytoin sodium 50 mg/mLInjectionIntramuscular, IntravenousHenry Schein, Inc.0404-980800404-9808-05
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralUnichem Pharmaceuticals (USA), Inc.29300-37929300-0379-0129300-0379-0529300-0379-10
Phenytoin SodiumPhenytoin sodium 50 mg/mLInjectionIntramuscular, IntravenousHenry Schein, Inc.0404-993200404-9932-02
Phenytoin SodiumPhenytoin sodium 50 mg/mLInjectionIntramuscular, IntravenousAcella Pharmaceuticals, LLC42192-61442192-0614-1042192-0614-30
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-229370518-2293-0070518-2293-01
Phenytoin SodiumPhenytoin sodium 50 mg/mLInjectionIntramuscular, IntravenousHF Acquisition Co LLC, DBA HealthFirst51662-125051662-1250-01
Phenytoin SodiumPhenytoin sodium 50 mg/mLInjectionIntramuscular, IntravenousHF Acquisition Co LLC, DBA HealthFirst51662-125151662-1251-0151662-1251-03

All 27 Phenytoin Sodium NDCs

Other NDCs under ANDA 040684

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

FDA NDC Directory listings under ANDA 040684
ProductStrengthForm · routeLabelerProduct NDC
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralCoupler LLC67046-0585
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralProficient Rx LP82804-269
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-869
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralAvPAK50268-719
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7416
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralSun Pharmaceutical Industries, Inc.51672-4111
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-934
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-0107
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-3539
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-982
Phenytoin SodiumPhenytoin sodium 100 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-2293

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in