Prescription drug · ANDA
Divalproex Sodium NDC 65862-959
Divalproex sodium 125 mg/1 · Tablet, Delayed release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-959-01 | 6586209590165862095901 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-959-01)Marketed from Oct 24, 2014 | |
| 65862-959-05 | 6586209590565862095905 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-959-05)Marketed from Oct 24, 2014 | |
| 65862-959-10 | 6586209591065862095910 | 10 BLISTER PACK in 1 CARTON (65862-959-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Oct 24, 2014 | |
| 65862-959-71 | 6586209597165862095971 | 7000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-959-71)Marketed from Oct 24, 2014 | |
| 65862-959-99 | 6586209599965862095999 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-959-99)Marketed from Oct 24, 2014 |
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 — 125 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090554
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 65862-959_3b5e2f9c-96b3-4b68-b0bb-91b0f4ef344bSPL ID 3b5e2f9c-96b3-4b68-b0bb-91b0f4ef344bSPL set ID dbd47222-14f1-4588-a009-9b81b55ca60dRxCUI 1099625, 1099678, 1099870UNII 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
N465862095901followed by a unit qualifier and the quantityPackage 65862-0959-01. 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 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 tablets are a valproate and are 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, motor hyperac…
Excerpt only. Read the full label for complete information.
About NDC 65862-959
- What is NDC 65862-959?
- 65862-959 is the product NDC for Divalproex Sodium, Divalproex sodium 125 mg/1 tablet, delayed release, listed with the FDA by Aurobindo Pharma Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Divalproex Sodium.
- What is the active ingredient?
- Divalproex sodium.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Divalproex Sodium?
- 185 other product NDCs are listed under this name. See all Divalproex Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Divalproex Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| divalproex sodium | Divalproex sodium 250 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-1696 | 67046-1696-03 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | 55154-0577 | 55154-0577-00 |
| divalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-4193 | 68788-4193-0368788-4193-0668788-4193-09 |
| divalproex sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Coupler LLC | 67046-1683 | 67046-1683-03 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-027 | 87441-0027-01 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-028 | 87441-0028-01 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-2021 | 67046-2021-03 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-4100 | 68788-4100-0368788-4100-0668788-4100-09 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Film coated, Extended releaseOral | Safecor Health, LLC | 48433-033 | 48433-0033-08 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Film coated, Extended releaseOral | Safecor Health, LLC | 48433-034 | 48433-0034-08 |
Other NDCs under ANDA 090554
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 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7121 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Rising Pharma Holdings, Inc. | 57237-047 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Rising Pharma Holdings, Inc. | 57237-048 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | Rising Pharma Holdings, Inc. | 57237-106 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-698 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Aurobindo Pharma Limited | 65862-402 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Aurobindo Pharma Limited | 65862-403 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 68084-776 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 68084-782 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-2357 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-3055 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-3683 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2158 |