Prescription drug · ANDA
Divalproex Sodium NDC 68788-4100
Divalproex sodium 500 mg/1 · Tablet, Extended release · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4100-3 | 68788410003 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4100-3)Marketed from Apr 20, 2026 | |
| 68788-4100-6 | 68788410006 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4100-6)Marketed from Apr 20, 2026 | |
| 68788-4100-9 | 68788410009 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-4100-9)Marketed from Apr 20, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Divalproex Sodium
- Generic name (nonproprietary)
- divalproex sodium
- Active ingredients
- Divalproex sodium — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090070
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68788-4100_dc9e4871-fb3d-4c59-81e5-2ab6e8be9b7cSPL ID dc9e4871-fb3d-4c59-81e5-2ab6e8be9b7cSPL set ID dc9e4871-fb3d-4c59-81e5-2ab6e8be9b7cRxCUI 1099569UNII 644VL95AO6
- 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
N468788410003followed by a unit qualifier and the quantityPackage 68788-4100-03. 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)
Divalproex sodium extended-release tablet is indicated for: • Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1) • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2) • Prophylaxis of migraine headaches (1.3) 1.1 Mania Divalproex sodium extended-release tablet is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elev…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090070
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 |
|---|---|---|---|---|
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddy's Laboratories Ltd | 55111-534 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.