Prescription drug · ANDA
Divalproex Sodium NDC 55154-5633
Divalproex sodium 500 mg/1 · Tablet, Delayed release · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-5633-0 | 55154563300 | 10 BLISTER PACK in 1 BAG (55154-5633-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Apr 1, 2016 |
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, Delayed release
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078182
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 55154-5633_c8d211c4-2617-4f33-b0fd-f1deda2a939cSPL ID c8d211c4-2617-4f33-b0fd-f1deda2a939cSPL set ID 4fc50afb-67f3-4bf3-9ec3-cc12734f47fdRxCUI 1099870UNII 644VL95AO6UPC 0055154563307
- 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
N455154563300followed by a unit qualifier and the quantityPackage 55154-5633-00. 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 tablets are 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 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 pressure of speech, mo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078182
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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-031 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-032 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | Upsher-Smith Laboratories, LLC | 0832-7122 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Upsher-Smith Laboratories, LLC | 0832-7123 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Upsher-Smith Laboratories, LLC | 0832-7124 |