Prescription drug · ANDA
Divalproex Sodium NDC 55111-534
Divalproex sodium 500 mg/1 · Tablet, Film coated, Extended release · Oral · Dr. Reddy's Laboratories Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-534-01 | 55111053401 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-534-01)Marketed from Aug 11, 2013 | |
| 55111-534-05 | 55111053405 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-534-05)Marketed from Aug 11, 2013 | |
| 55111-534-30 | 55111053430 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-534-30)Marketed from Aug 11, 2013 | |
| 55111-534-60 | 55111053460 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-534-60)Marketed from Aug 11, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Film coated, Extended release
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories Ltd
- 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 55111-534_65caa41f-3e0b-c418-b098-f4d0d8d9f31dSPL ID 65caa41f-3e0b-c418-b098-f4d0d8d9f31dSPL set ID fa823ee0-0c69-6b85-da1e-9bb2e2150ea5RxCUI 1099569UNII 644VL95AO6UPC 0355111534013
- 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
N455111053401followed by a unit qualifier and the quantityPackage 55111-0534-01. 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 elevated, …
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, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-4100 |
- 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.