Valproic Acid NDC 72603-253

NDC codes

FDA NDC Directory

Product NDC (as listed)72603-253Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72603-0253Add 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
72603-253-01	72603025301	473 mL in 1 BOTTLE (72603-253-01)Marketed from Jun 10, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073178
Marketing start: Jun 10, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 72603-253_1286acbf-3497-5aed-e063-6294a90af8beSPL ID 1286acbf-3497-5aed-e063-6294a90af8beSPL set ID 1286ab49-fa34-488e-e063-6394a90ad582RxCUI 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

N472603025301 followed by a unit qualifier and the quantity

Package 72603-0253-01. 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 May 27, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Valproic acid oral solution 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 oral solution 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 oral solution 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 whi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 073178

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

FDA NDC Directory listings under ANDA 073178
Product	Strength	Form · route	Labeler	Product NDC
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	ANI Pharmaceuticals, Inc.	62559-266
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	REMEDYREPACK INC.	70518-4298
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	Kesin Pharma Corporation	81033-266