Prescription drug · NDA
Depakote (Divalproex sodium) NDC 0074-7326
Divalproex sodium 250 mg/1 · Tablet, Delayed release · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-7326-13 | 0007473261300074732613 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7326-13)Marketed from Jun 30, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Depakote
- Generic name (nonproprietary)
- divalproex sodium
- Active ingredients
- Divalproex sodium — 250 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018723
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 0074-7326_7cc3a0b3-93f8-4825-88e1-bf6ddb0db23dSPL ID 7cc3a0b3-93f8-4825-88e1-bf6ddb0db23dSPL set ID 08a65cf4-7749-4ceb-6895-8f4805e2b01fRxCUI 1099625, 1099626, 1099678, 1099679, 1099870, 1099871UNII 644VL95AO6UPC 0300747327133, 0300747325139
- 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
N400074732613followed by a unit qualifier and the quantityPackage 00074-7326-13. 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)
Depakote 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 Depakote (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 ne…
Excerpt only. Read the full label for complete information.
About NDC 0074-7326
- What is NDC 0074-7326?
- 0074-7326 is the product NDC for Depakote (divalproex sodium), Divalproex sodium 250 mg/1 tablet, delayed release, listed with the FDA by AbbVie Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Depakote (Divalproex Sodium).
- What is the active ingredient?
- Divalproex sodium.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Depakote?
- 2 other product NDCs are listed under this name. See all Depakote NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Depakote products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Depakotedivalproex sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | AbbVie Inc. | 0074-7325 | 00074-7325-13 |
| Depakotedivalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | AbbVie Inc. | 0074-7327 | 00074-7327-13 |
Other NDCs under NDA 018723
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 |
|---|---|---|---|---|
| Depakotedivalproex sodium | Divalproex sodium 125 mg/1 | Tablet, Delayed releaseOral | AbbVie Inc. | 0074-7325 |
| Depakotedivalproex sodium | Divalproex sodium 500 mg/1 | Tablet, Delayed releaseOral | AbbVie Inc. | 0074-7327 |