Prescription drug · ANDA
Valproic Acid NDC 0904-7620
Valproic acid 250 mg/5mL · Solution · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7620-70 | 00904762070 | 10 TRAY in 1 CASE (0904-7620-70) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7620-41)Marketed from Aug 3, 2026 | |
| 0904-7620-94 | 00904762094 | 4 TRAY in 1 CASE (0904-7620-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7620-41)Marketed from Aug 3, 2026 |
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
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075379
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0904-7620_3aea592e-0fb0-4853-83d1-41b2d13c5302SPL ID 3aea592e-0fb0-4853-83d1-41b2d13c5302SPL set ID a33f7657-ad0f-43e9-ba48-024746e6d08eRxCUI 1099687UNII 614OI1Z5WIUPC 0309047621668, 0309047620418
- 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
N400904762070followed by a unit qualifier and the quantityPackage 00904-7620-70. 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 . 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.
Other NDCs under ANDA 075379
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0675 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | REMEDYREPACK INC. | 70518-3805 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | American Health Packaging | 60687-942 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | American Health Packaging | 60687-953 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4675 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | Major Pharmaceuticals | 0904-7621 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | Bryant Ranch Prepack | 71335-2250 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1350 |