Prescription drug · ANDA
Divalproex sodium NDC 0615-8237
Divalproex sodium 125 mg/1 · Capsule · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8237-05 | 00615823705 | 15 CAPSULE in 1 BLISTER PACK (0615-8237-05)Marketed from Aug 27, 2018 | |
| 0615-8237-28 | 00615823728 | 28 CAPSULE in 1 BLISTER PACK (0615-8237-28)Marketed from Apr 19, 2024 | |
| 0615-8237-30 | 00615823730 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8237-30) / 5 CAPSULE in 1 BLISTER PACKMarketed from Aug 27, 2018 | |
| 0615-8237-39 | 00615823739 | 30 CAPSULE in 1 BLISTER PACK (0615-8237-39)Marketed from Aug 27, 2018 |
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 — 125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078979
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0615-8237_9acc51b3-fd1c-48a4-b620-689c38545dd5SPL ID 9acc51b3-fd1c-48a4-b620-689c38545dd5SPL set ID 388fd4bc-f12f-4e55-a1e7-72aa585519faRxCUI 1099596UNII 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
N400615823705followed by a unit qualifier and the quantityPackage 00615-8237-05. 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 delayed-release capsule is an anti-epileptic drug indicated for : 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) 1.1 Epilepsy Divalproex sodium delayed-release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release capsules are also indicated for use as sole and adjunctive therapy in the treatmen…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078979
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 125 mg/1 | Capsule, Delayed releaseOral | NorthStar Rx LLC | 72603-260 |
| Divalproex sodium | Divalproex sodium 125 mg/1 | Capsule, Delayed releaseOral | Cardinal Health 107, LLC | 55154-3552 |
| Divalproex sodium | Divalproex sodium 125 mg/1 | Capsule, Delayed releaseOral | Major Pharmaceuticals | 0904-6615 |
| Divalproex sodium | Divalproex sodium 125 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Ltd | 55111-532 |