Prescription drug · ANDA
Divalproex Sodium NDC 62756-796
Divalproex sodium 125 mg/1 · Tablet, Delayed release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-796-08 | 6275607960862756079608 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-08)Marketed from Jul 29, 2008 | |
| 62756-796-13 | 6275607961362756079613 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-13)Marketed from Jul 29, 2008 | |
| 62756-796-18 | 6275607961862756079618 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-18)Marketed from Jul 29, 2008 | |
| 62756-796-83 | 6275607968362756079683 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-83)Marketed from Jul 29, 2008 | |
| 62756-796-88 | 6275607968862756079688 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-796-88)Marketed from Jul 29, 2008 |
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
- Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078597
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 62756-796_9fa8a32e-7def-4ae6-b537-15450ef34bc2SPL ID 9fa8a32e-7def-4ae6-b537-15450ef34bc2SPL set ID 64797788-fdcb-4d12-a1a4-743ad71bd17bRxCUI 1099625, 1099678, 1099870UNII 644VL95AO6UPC 0362756796836, 0362756798830
- 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
N462756079608followed by a unit qualifier and the quantityPackage 62756-0796-08. 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 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, motor hyperactivity, reduced need…
Excerpt only. Read the full label for complete information.
About NDC 62756-796
- What is NDC 62756-796?
- 62756-796 is the product NDC for Divalproex Sodium, Divalproex sodium 125 mg/1 tablet, delayed release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. 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 078597
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 | Major Pharmaceuticals | 0904-6860 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-1558 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | 55154-0577 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-2674 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Sun Pharmaceutical Industries, Inc. | 62756-798 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Major Pharmaceuticals | 0904-6861 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-2316 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3553 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | 55154-2336 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-7635 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2277 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-353 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-354 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Sun Pharmaceutical Industries, Inc. | 62756-797 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2344 |
| Divalproex Sodium D/R | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Direct_Rx | 72189-636 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-1123 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 107, LLC | 55154-4154 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8609 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-798 |
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