What is NDC 0121-0892?

0121-0892 is the product NDC for Phenytoin, Phenytoin 125 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phenytoin NDC 0121-0892 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0892Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0892Add 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 NDC	11-digit (billing)	Package	Copy
0121-0892-63	0012108926300121089263	4 mL in 1 CUP, UNIT-DOSE (0121-0892-63)Marketed from Apr 8, 2004

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 — 125 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040521
Marketing start: Apr 8, 2004
Listing expires: Dec 31, 2026
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 0121-0892_4daa397f-237b-4327-91bd-d86b19e4b9b2SPL ID 4daa397f-237b-4327-91bd-d86b19e4b9b2SPL set ID f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15RxCUI 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

N400121089263 followed by a unit qualifier and the quantity

Package 00121-0892-63. 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 Nov 19, 2024.

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)

About NDC 0121-0892

What is NDC 0121-0892?: 0121-0892 is the product NDC for Phenytoin, Phenytoin 125 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, 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?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Phenytoin	Phenytoin 50 mg/1	Tablet, ChewableOral	Rising Pharma Holdings, Inc.	64980-573	64980-0573-01
Phenytoin	Phenytoin 125 mg/5mL	SuspensionOral	Mylan Pharmaceuticals Inc.	59762-0531	59762-0531-02
Phenytoin	Phenytoin 125 mg/5mL	SuspensionOral	American Health Packaging	60687-275	60687-0275-66
Phenytoin	Phenytoin 50 mg/1	Tablet, ChewableOral	REMEDYREPACK INC.	70518-0841	70518-0841-0070518-0841-03
Phenytoin	Phenytoin 50 mg/1	Tablet, ChewableOral	American Health Packaging	60687-156	60687-0156-25
Phenytoin	Phenytoin 50 mg/1	Tablet, ChewableOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8623	00615-8623-39
Phenytoin	Phenytoin 50 mg/1	Tablet, ChewableOral	Major Pharmaceuticals	0904-7199	00904-7199-07
Phenytoin	Phenytoin 50 mg/1	Tablet, ChewableOral	Sun Pharmaceutical Industries, Inc.	51672-4146	51672-4146-0151672-4146-0351672-4146-06
Phenytoin	Phenytoin 125 mg/5mL	SuspensionOral	ATLANTIC BIOLOGICALS CORP.	17856-4070	17856-4070-01
Phenytoin	Phenytoin 125 mg/5mL	SuspensionOral	Sun Pharmaceutical Industries, Inc.	51672-4069	51672-4069-02

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
Product	Strength	Form · route	Labeler	Product NDC
Phenytoin	Phenytoin 125 mg/5mL	SuspensionOral	ATLANTIC BIOLOGICALS CORP.	17856-4070
Phenytoin	Phenytoin 125 mg/5mL	SuspensionOral	Sun Pharmaceutical Industries, Inc.	51672-4069
Phenytoin	Phenytoin 125 mg/5mL	SuspensionOral	American Health Packaging	60687-275