Prescription drug · ANDA
Divalproex Sodium NDC 68180-265
Divalproex sodium 125 mg/1 · Tablet, Delayed release · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Divalproex Sodium
- Generic name (nonproprietary)
- divalproex sodium
- Active ingredients
- Divalproex sodium — 125 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078790
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68180-265_0a9f300c-ee8c-43c4-bccf-78cd862a7ac2SPL ID 0a9f300c-ee8c-43c4-bccf-78cd862a7ac2SPL set ID 33798a7c-c5a9-49a5-be5d-1312910ef468RxCUI 1099625, 1099678, 1099870UNII 644VL95AO6UPC 0368180267010
- 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Divalproex sodium delayed-release tablet is an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder ( 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 delayed-release tablet is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078790
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, Delayed releaseOral | Lupin Pharmaceuticals, Inc. | 68180-266 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Lupin Pharmaceuticals, Inc. | 68180-267 |