Prescription drug · ANDA
Divalproex sodium NDC 0615-8377
Divalproex sodium 500 mg/1 · Tablet, Extended release · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8377-39 | 00615837739 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8377-39)Marketed from Feb 3, 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)
- 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 209286
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0615-8377_be5c8101-031d-436c-a3ba-6816e2922bb3SPL ID be5c8101-031d-436c-a3ba-6816e2922bb3SPL set ID 319bbead-bec8-4bb7-9ecb-b2e161c44b8dRxCUI 1099563, 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
N400615837739followed by a unit qualifier and the quantityPackage 00615-8377-39. 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 tablets are 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 tablets are valproate and are 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 ele…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209286
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 250 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-286 |
| Divalproex sodium | Divalproex sodium 250 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3183 |
| Divalproex Sodium ER | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-459 |
| Divalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-1883 |
| Divalproex sodium | Divalproex sodium 250 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8376 |
| Divalproex sodium | Divalproex sodium 250 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-260 |
| Divalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-261 |
| Divalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-3477 |
| Divalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-8358 |