Prescription drug · ANDA
Valproic Acid NDC 62135-196
Valproic acid 250 mg/5mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-196-24 | 62135019624 | 2 TRAY in 1 BOX (62135-196-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45)Marketed from May 28, 2024 | |
| 62135-196-47 | 62135019647 | 473 mL in 1 BOTTLE (62135-196-47)Marketed from Aug 15, 2022 |
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
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075782
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 62135-196_5071bcb9-2d2f-24e3-e063-6294a90a8e56SPL ID 5071bcb9-2d2f-24e3-e063-6294a90a8e56SPL set ID 8051ad62-3b6e-461e-8090-60f5c0a904f4RxCUI 1099687UNII 614OI1Z5WIUPC 0362135196479
- 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
N462135019624followed by a unit qualifier and the quantityPackage 62135-0196-24. 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 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.
Other NDCs under ANDA 075782
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 500 mg/10mL | SolutionOral | Chartwell RX, LLC | 62135-874 |
| Valproic Acid | Valproic acid 250 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-196 |
| Valproic Acid | Valproic acid 500 mg/10mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-874 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.