What is NDC 0121-0675?

0121-0675 is the product NDC for Valproic Acid, Valproic acid 250 mg/5mL solution, 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 Valproic Acid?

27 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valproic Acid NDC 0121-0675 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0675Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0675Add 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
0121-0675-85	00121067585	473 mL in 1 BOTTLE (0121-0675-85)Marketed from Aug 11, 2021

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): Valproic Acid
Generic name (nonproprietary): valproic acid
Active ingredients: Valproic acid — 250 mg/5mL
Dosage form: Solution
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 075379
Marketing start: Apr 11, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 0121-0675_4ba53689-4707-46fc-8943-48f186e04e73SPL ID 4ba53689-4707-46fc-8943-48f186e04e73SPL set ID 7d5cb52e-37dd-4dfa-a6f4-09f9548846c6RxCUI 1099687UNII 614OI1Z5WI
Pharmacologic class: Anti-epileptic Agent; Mood Stabilizer

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

N400121067585 followed by a unit qualifier and the quantity

Package 00121-0675-85. 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 Jan 24, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Valproic acid is indicated for: Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1 ) 1.1 Epilepsy Valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. Simple absenc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0675

What is NDC 0121-0675?: 0121-0675 is the product NDC for Valproic Acid, Valproic acid 250 mg/5mL solution, 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?: Valproic Acid.
What is the active ingredient?: Valproic acid.
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 Valproic Acid?: 27 other product NDCs are listed under this name. See all Valproic Acid 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 Valproic Acid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	American Health Packaging	60687-942	60687-0942-1760687-0942-77
Valproic Acid	Valproic acid 500 mg/10mL	SolutionOral	American Health Packaging	60687-953	60687-0953-56
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	Major Pharmaceuticals	0904-7620	00904-7620-7000904-7620-94
Valproic Acid	Valproic acid 500 mg/10mL	SolutionOral	Major Pharmaceuticals	0904-7621	00904-7621-72
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	REMEDYREPACK INC.	70518-4298	70518-4298-0070518-4298-0270518-4298-04
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	NorthStar Rx LLC	72603-253	72603-0253-01
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	QUAGEN PHARMACEUTICALS LLC	70752-202	70752-0202-12
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	Kesin Pharma Corporation	81033-266	81033-0266-5081033-0266-52
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	ANI Pharmaceuticals, Inc.	62559-266	62559-0266-16
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	REMEDYREPACK INC.	70518-3805	70518-3805-0070518-3805-02

All 28 Valproic Acid NDCs

Other NDCs under ANDA 075379

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

FDA NDC Directory listings under ANDA 075379
Product	Strength	Form · route	Labeler	Product NDC
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	American Health Packaging	60687-942
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-4675
Valproic Acid	Valproic acid 500 mg/10mL	SolutionOral	American Health Packaging	60687-953
Valproic Acid	Valproic acid 500 mg/10mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1350
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	Bryant Ranch Prepack	71335-2250
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	Major Pharmaceuticals	0904-7620
Valproic Acid	Valproic acid 500 mg/10mL	SolutionOral	Major Pharmaceuticals	0904-7621
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	REMEDYREPACK INC.	70518-3805