Prescription drug · ANDA
Divalproex Sodium NDC 68001-474
Divalproex sodium 500 mg/1 · Tablet, Delayed release · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-474-00 | 68001047400 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-474-00)Marketed from Jan 20, 2021 | |
| 68001-474-03 | 68001047403 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-474-03)Marketed from Jan 20, 2021 |
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, Delayed release
- Route
- Oral
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079163
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68001-474_52558612-806d-932f-e063-6394a90a4789SPL ID 52558612-806d-932f-e063-6394a90a4789SPL set ID b95494e2-ee7a-7415-e053-2995a90ae852RxCUI 1099625, 1099678, 1099870UNII 644VL95AO6UPC 0368001474009, 0368001473002, 0368001472005
- 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
N468001047400followed by a unit qualifier and the quantityPackage 68001-0474-00. 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 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 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 hype…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079163
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, Delayed releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-140 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-028 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-138 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-139 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2862 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-473 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-472 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-2460 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2885 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-857 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-027 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-868 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | American Health Packaging | 60687-879 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-2124 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-2007 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-743 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-742 |
| Divalproex Sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | DirectRx | 61919-249 |
| Divalproex Sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-4861 |
| Divalproex Sodium | Divalproex sodium 250 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-0008 |
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